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CompletedNCT04376762Updated Mar 6, 2026Results posted

Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

A Phase 4 interventional study of Fibrinogen and Cryoprecipitate in Pediatric HD and Bleeding, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by University of Virginia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
Up to 24 Months
Sex
All
01

Study summary

The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated.

The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients.

Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):

  1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or
  2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC).

The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below).

Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.

Read the detailed description

Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):

  1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or
  2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who initially received FC).

Data to be obtained:

  1. Demographic/preoperative data: collected from the medical record

    • age in days/months (all patients to be younger than 24 months)
    • gender
    • weight
    • preoperative diagnosis
    • surgery type \& date (Norwood, arterial switch, truncus arteriosus, Glenn, Fontan, TAPVR, AV canal, tetralogy of Fallot, etc)
    • preoperative standard of care labs PT/aPTT/INR/hgb level/ hematocrit/ platelet count/ fibrinogen level (if exists)/ creatinine

  2. Intra-operative Data:

    • CPB time \& aortic cross clamp time
    • use of hypothermic circulatory arrest (ice packs placed on the head)
    • was post-CPB ultrafiltration performed?
    • Platelet count prior to separation from CPB
    • was ATIII administered? (thrombate)
    • Transfusion requirements: PRBC/Cell Saver/FFP/PLT/ cryo - to be collected as number of units per each product, not volume. (for PLT - was it pooled PLT or single donor apheresis, if possible)
    • was rFVIIa given (factor seven, novoseven). Please pay attention - the fact that rFVIIa was ordered DOES NOT mean that was actually administered as we order factor VII for ALL big cases (to have available in the OR) but not necessarily administer it
    • Need for ECMO
    • Was the chest left open? (always in ECMO, but open chest does not necessarily mean ECMO)

  3. Postoperative Data

    • admission PT/aPTT/INR/platelet count/ fibrinogen level/ hgb level/HCT level (could be obtained from initial ABG)
    • Bleeding (Chest drain/s output)
    • Need for additional transfusion (PRBC/cell saver/FFP/platelets/cryoprecipitate). Will need to know, if possible, whether transfused from same unit that was already exposed to in the OR or new unit (= new exposure)
    • Factor VIIa administration
    • re-exploration? (= starting ECMO in the PICU)
    • delayed chest closure? (will answer whether went to PICU with chest open)
02

Conditions studied

  • Pediatric HD
  • Bleeding

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 31 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).

Exclusion criteria

Exclusion Criteria:

  • gestational age \< 33 weeks at birth
  • gestational age \< 35 weeks on the day of surgery
  • emergency surgery
  • patient or parent history of coagulopathy/clotting abnormalities
  • patient history of thrombophilia
  • refusal to participate in the study,
  • known severe allergic reaction/anaphylaxis to fibrinogen concentrate,
  • administration of fibrinogen concentrate or cryoprecipitate in the 24 hours prior to surgery
  • baseline fibrinogen level higher than 300 mg/dL (to avoid the risk of increasing the fibrinogen level above the normal upper level of 400 mg/dL)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Fibrinogen Concentrate

    Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).

    Drug: Fibrinogen

  • Active comparator
    Cryoprecipitate

    . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).

    Drug: Cryoprecipitate

Interventions

  • DrugFibrinogen

    Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).

    Also known as: Fibrinogen Concentrate (Human) Injection [Fibryga]

  • DrugCryoprecipitate

    Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).

06

What researchers measure

Primary outcomes

  1. A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery

    comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU

    Time frame: from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit

Secondary outcomes

  1. Comparison of Post CPB Bleeding (in ml) Between the Study Groups

    (intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml)

    Time frame: from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU

  2. Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

    Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

    Time frame: From immediately after study medication administration through postoperative day 7

  3. Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

    Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

    Time frame: From immediately after study medication administration through postoperative day 7

  4. Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

    Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

    Time frame: From immediately after study medication administration through postoperative day 7

  5. Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

    Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

    Time frame: From immediately after study medication administration through postoperative day 7

  6. Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade

    Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade

    Time frame: from admission to the ICU until postoperative day 7

  7. Incidence of the Use of Factor VIIa for Bleeding

    comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups

    Time frame: from separation from CPB until 48 hours after surgery

  8. In-hospital Mortality

    comparison of the incidence of in-hospital mortality between the study groups

    Time frame: from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)

  9. Post Operative Acute Kidney Injury (AKI)

    comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome)

    Time frame: from admission to the ICU until postoperative day 7

  10. Postoperative Infection

    comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups

    Time frame: rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)

  11. Percent of Patients With Postoperative Neurological Injury

    Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery

    Time frame: from admission to the ICU until POD 7

  12. Intubation Time

    comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups

    Time frame: from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)

  13. Postoperative Thromboembolic Event

    comparison of the incidence of DVT/PE/shunt thrombosis between the study groups

    Time frame: from admission to the ICU until 7 days postoperatively

  14. ICU Length of Stay

    comparison of the postoperative time period spent in the ICU

    Time frame: from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)

  15. Hospital Length of Stay

    comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital

    Time frame: from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)

07

Results

Posted Mar 6, 2026

Participant flow

Participant flow — Overall Study
MilestoneFibrinogen ConcentrateCryoprecipitate
Started1615
Completed1115
Not completed50
Withdrew: No bleeding after cardiopulmonary bypass (cpb)30
Withdrew: Avoidance of cpb10
Withdrew: No evidence of hypofibrinogenemia10

Outcome measures

PrimaryA Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery

comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU

Time frame:
from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit
Reported as:
Mean · allogeneic blood products
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery
allogeneic blood productsFibrinogen ConcentrateCryoprecipitate
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery3.4 (2 to 6)4.5 (3 to 6)
SecondaryComparison of Post CPB Bleeding (in ml) Between the Study Groups

(intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml)

Time frame:
from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU
Reported as:
Mean · mL
Comparison of Post CPB Bleeding (in ml) Between the Study Groups
mLFibrinogen ConcentrateCryoprecipitate
Comparison of Post CPB Bleeding (in ml) Between the Study Groups48.7 (35 to 81)46.2 (30 to 73)
SecondaryComparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Time frame:
From immediately after study medication administration through postoperative day 7
Reported as:
Median · RBC units
Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
RBC unitsFibrinogen ConcentrateCryoprecipitate
Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 70 (0 to 0)0 (0 to 0)
SecondaryComparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Time frame:
From immediately after study medication administration through postoperative day 7
Reported as:
Median · platelets units
Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
platelets unitsFibrinogen ConcentrateCryoprecipitate
Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 71 (1 to 1)1 (1 to 1)
SecondaryComparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Time frame:
From immediately after study medication administration through postoperative day 7
Reported as:
Median · plasma units
Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
plasma unitsFibrinogen ConcentrateCryoprecipitate
Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 70 (0 to 0)0 (0 to 0)
SecondaryComparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7

Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Time frame:
From immediately after study medication administration through postoperative day 7
Reported as:
Median · additional cryoprecipitate units
Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
additional cryoprecipitate unitsFibrinogen ConcentrateCryoprecipitate
Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 70 (0 to 0)0 (0 to 0)
SecondaryNumber of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade

Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade

Time frame:
from admission to the ICU until postoperative day 7
Reported as:
Count of participants · Participants
Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade
ParticipantsFibrinogen ConcentrateCryoprecipitate
Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade10
SecondaryIncidence of the Use of Factor VIIa for Bleeding

comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups

Time frame:
from separation from CPB until 48 hours after surgery
Reported as:
Count of participants · Participants
Incidence of the Use of Factor VIIa for Bleeding
ParticipantsFibrinogen ConcentrateCryoprecipitate
Incidence of the Use of Factor VIIa for Bleeding03
SecondaryIn-hospital Mortality

comparison of the incidence of in-hospital mortality between the study groups

Time frame:
from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Reported as:
Count of participants · Participants
In-hospital Mortality
ParticipantsFibrinogen ConcentrateCryoprecipitate
In-hospital Mortality00
SecondaryPost Operative Acute Kidney Injury (AKI)

comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome)

Time frame:
from admission to the ICU until postoperative day 7
Reported as:
Count of participants · Participants
Post Operative Acute Kidney Injury (AKI)
ParticipantsFibrinogen ConcentrateCryoprecipitate
Post Operative Acute Kidney Injury (AKI)10
SecondaryPostoperative Infection

comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups

Time frame:
rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Reported as:
Count of participants · Participants
Postoperative Infection
ParticipantsFibrinogen ConcentrateCryoprecipitate
Postoperative Infection00
SecondaryPercent of Patients With Postoperative Neurological Injury

Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery

Time frame:
from admission to the ICU until POD 7
Reported as:
Count of participants · Participants
Percent of Patients With Postoperative Neurological Injury
ParticipantsFibrinogen ConcentrateCryoprecipitate
Percent of Patients With Postoperative Neurological Injury02
SecondaryIntubation Time

comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups

Time frame:
from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)
Reported as:
Number
Intubation Time
MeasureFibrinogen ConcentrateCryoprecipitate
Intubation TimeNANA
SecondaryPostoperative Thromboembolic Event

comparison of the incidence of DVT/PE/shunt thrombosis between the study groups

Time frame:
from admission to the ICU until 7 days postoperatively
Reported as:
Count of participants · Participants
Postoperative Thromboembolic Event
ParticipantsFibrinogen ConcentrateCryoprecipitate
Postoperative Thromboembolic Event02
SecondaryICU Length of Stay

comparison of the postoperative time period spent in the ICU

Time frame:
from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)
Reported as:
Mean · days
ICU Length of Stay
daysFibrinogen ConcentrateCryoprecipitate
ICU Length of Stay15.2 ± 19.110.5 ± 12.5
SecondaryHospital Length of Stay

comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital

Time frame:
from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)
Reported as:
Mean · days
Hospital Length of Stay
daysFibrinogen ConcentrateCryoprecipitate
Hospital Length of Stay23.8 ± 2715.5 ± 16.4

Adverse events

Collected over Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fibrinogen Concentrate0/11 (0%)1/11 (9.1%)0/11 (0%)
Cryoprecipitate0/15 (0%)0/15 (0%)3/15 (20%)
Most frequent serious events
Most frequent serious events
EventFibrinogen ConcentrateCryoprecipitate
Acute Kidney InjuryRenal and urinary disorders1/110/15
CardioversionCardiac disorders1/110/15
Most frequent other events
Most frequent other events
EventFibrinogen ConcentrateCryoprecipitate
Seizure/StrokeNervous system disorders0/112/15
Internal Chest Compressions and PacingCardiac disorders0/111/15

Baseline characteristics

The data consists of a total of 31 cases. However, as CPB was not performed for one patient (ID #29; in the Fibrygagroup), therefore this patient was excluded.

Age, Categorical
Age, Categorical(Participants)Fibrinogen ConcentrateCryoprecipitateTotal
<=18 years151530
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(months)Fibrinogen ConcentrateCryoprecipitateTotal
Mean4.6 ± 3.75.2 ± 5.14.9 ± 4.39
Sex: Female, Male
Sex: Female, Male(Participants)Fibrinogen ConcentrateCryoprecipitateTotal
Female3912
Male12618
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Fibrinogen ConcentrateCryoprecipitateTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Fibrinogen ConcentrateCryoprecipitateTotal
United States151526
Weight
Weight(kg)Fibrinogen ConcentrateCryoprecipitateTotal
Mean5.8 ± 2.15.3 ± 1.75.55 ± 1.89
08

Study locations

1 site
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
09

References and documents

Publications

  • Hvas AM, Andreasen JB, Christiansen K, Ravn HB. Ex-vivo response to blood products and haemostatic agents after paediatric cardiac surgery. Blood Coagul Fibrinolysis. 2013 Sep;24(6):587-92. doi: 10.1097/MBC.0b013e32836029d2. PubMed 23571685 ↗
  • Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18. PubMed 24951020 ↗
  • Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15. PubMed 25982134 ↗
  • Haas T, Cushing MM, Asmis LM. Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro. Scand J Clin Lab Invest. 2018 May;78(3):230-235. doi: 10.1080/00365513.2018.1437645. Epub 2018 Feb 15. PubMed 29446989 ↗
  • Ranucci M, Baryshnikova E, Crapelli GB, Rahe-Meyer N, Menicanti L, Frigiola A; Surgical Clinical Outcome REsearch (SCORE) Group. Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Am Heart Assoc. 2015 Jun 2;4(6):e002066. doi: 10.1161/JAHA.115.002066. PubMed 26037084 ↗
  • Fassl J, Lurati Buse G, Filipovic M, Reuthebuch O, Hampl K, Seeberger MD, Bolliger D. Perioperative administration of fibrinogen does not increase adverse cardiac and thromboembolic events after cardiac surgery. Br J Anaesth. 2015 Feb;114(2):225-34. doi: 10.1093/bja/aeu364. Epub 2014 Oct 16. PubMed 25324348 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 5, 2020
  • Informed consent form · Sep 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04376762
Lead sponsor
University of Virginia
Collaborators
Octapharma
Responsible party
Jacob Raphael (Professor UVA Department of Anesthesiology, University of Virginia) — Principal investigator
First posted
May 6, 2020
Start date
Oct 26, 2021
Primary completion
Mar 1, 2023
Completion
May 1, 2023
Results posted
Mar 6, 2026
Last update
Mar 6, 2026

Study contacts

Keita Ikeda, MD
study director · UVA Anesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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