CompletedNCT05711524Updated Nov 21, 2025Results posted

Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

A Phase 4 interventional study of Traditional Cryoprecipitate and Pathogen-Reduced Cryoprecipitate in Hypofibrinogenemia and Bleeding, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 208
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.

Participants will be given one of the two FDA-approved blood products.

Read the detailed description

Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.

Conditions studied

Hypofibrinogenemia
Bleeding

Browse trials for

Hemorrhage 3,000

Keywords

Cryoprecipitate
Pathogen Reduced Cryoprecipitate

In context

Hemorrhage

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

This study's enrollment of 208 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
Cardiovascular surgery includes the following procedures:
1. coronary artery bypass grafting
2. valve repair or replacement
3. open thoracic aortic and thoracoabdominal aortic surgery
4. atrial or ventricular septal defects
5. ventricular assist device implantation or revision
6. or any combination of the above.

Exclusion criteria

Exclusion Criteria:

Patients who do not receive any cryo product in the OR
Patients who are not cardiovascular surgery or liver transplant patients
Cardiac transplantation surgery
Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month.
Patients who receive less than 1 pool (5 units) of cryo
Pediatric patients (less than 18 years of age).
Patients who received both PR cryo and traditional cryo
Pregnant women

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 208 participants (actual)

Study arms

Active comparator
Patients given Traditional Cryo
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
Biological: Traditional Cryoprecipitate
Experimental
Patients given PR Cryo
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
Biological: Pathogen-Reduced Cryoprecipitate

Interventions

BiologicalTraditional Cryoprecipitate
This is the cryoprecipitate already currently being given to patients with a cryo order.
BiologicalPathogen-Reduced Cryoprecipitate
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.

What researchers measure

Primary outcomes

Total Number of RBCs Used Over Admission
RBCs used over admission
Time frame: Within the first 30 days after surgery.
Total Number of Platelets Used Over Admission
Plts used over admission
Time frame: Within the first 30 days after surgery.
Total Number of Plasma Used Over Admission
All units over admission
Time frame: Within the first 30 days after surgery.

Secondary outcomes

Number of Cryo Units Used Perioperatively
All products within 3 days
Time frame: 3 days post procedure
Number of RBCs Used Perioperatively
Number of RBC units transfused during perioperative period
Time frame: 3 days post procedure
Number of Plasma Used Perioperatively
Time frame: 3 days post procedure
Number of Platelets Used Perioperatively
Number of platelet units transfused during perioperative period
Time frame: 3 days post procedure
Time From Operating Room (OR) Start Time to Start of Cryo Transfusion
Time frame: procedure (Time from OR start time to start of cryo transfusion)
Time From Cryo Order to Start of Transfusion
Time to cryo order time to start of cryo transfusion
Time frame: procedure (Time from cryo order to start of transfusion)
Number of Cryo Units Wasted by Blood Bank
This captures the Cryoprecipitate units discarded.
Time frame: Daily, up to approximately 24 months
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation
FIBTEM before transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation
FIBTEM after transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Maximum Clot Firmness (MCF)
The maximum strength of a clot as determined by ROTEM testing.
Time frame: Variable, but it is generally available within 1 hour of the start of ROTEM testing.
Pre-transfusion Fibrinogen Level
The fibrinogen measurement before cryoprecipitate is transfused.
Time frame: During surgery, within 3 hours of specimen receipt by laboratory.
Highest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Lowest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal
The cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of drain removal
Time frame: Up to approximately 3 days
Volume in Drains (Chest Tube for CV Surgery)
Time frame: At 24 hours after surgery
Time From End of Bypass Pump for CV Surgery
Time frame: Until end of surgery
Length of Stay in OR
Operating room length of stay
Time frame: Duration of time in operating room
Length of Stay in ICU
Participant length of stay in ICU setting
Time frame: During hospitalization, approximately 5 days to 30 days
Length of Stay in Hospital
Overall length of stay in hospital
Time frame: During hospitalization, approximately 5 days to 30 days
Need for Ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Time on Ventilator
If participant was on ventilator, amount of time spent on ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Overall Cost of Cryo vs PR Cryo, When Factoring Wastage
Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.
Time frame: Daily, approximately 24 months
Number of Participants That Experienced an Adverse Event of Fever
All participants that experience fevers that occur during the time frame
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Infection
All participants that experience infections that occur during the time frame
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.
All participants that experience transfusion reactions that occur during the time frame
Time frame: Within 5 days of surgery start time
Fibrinogen Level
Fibrinogen level most proximal to the end of surgery
Time frame: Most proximal to end of procedure

Results

Posted Nov 21, 2025

Participant flow

Month 1 (Traditional Cryo)

Participant flow — Month 1 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	20	0
Completed	20	0
Not completed	0	0

Month 2 (PR Cryo)

Participant flow — Month 2 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	20
Completed	0	20
Not completed	0	0

Month 3 (PR Cryo)

Participant flow — Month 3 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	17
Completed	0	17
Not completed	0	0

Month 4 (Traditional Cryo)

Participant flow — Month 4 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	20	0
Completed	20	0
Not completed	0	0

Month 5 (Traditional Cryo)

Participant flow — Month 5 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	20	0
Completed	20	0
Not completed	0	0

Month 6 (PR Cryo)

Participant flow — Month 6 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	19
Completed	0	19
Not completed	0	0

Month 7 (Traditional Cryo)

Participant flow — Month 7 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	23	0
Completed	23	0
Not completed	0	0

Month 8 (PR Cryo)

Participant flow — Month 8 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	15
Completed	0	15
Not completed	0	0

Month 9 (PR Cryo)

Participant flow — Month 9 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	19
Completed	0	19
Not completed	0	0

Month 10 (Traditional Cryo)

Participant flow — Month 10 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	10	0
Completed	10	0
Not completed	0	0

Month 11 (PR Cryo)

Participant flow — Month 11 (PR Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	0	13
Completed	0	13
Not completed	0	0

Month 12 (Traditional Cryo)

Participant flow — Month 12 (Traditional Cryo)
Milestone	Patients Given Traditional Cryo	Patients Given PR Cryo
Started	12	0
Completed	12	0
Not completed	0	0

Outcome measures

PrimaryTotal Number of RBCs Used Over Admission

RBCs used over admission

Time frame:: Within the first 30 days after surgery.
Reported as:: Mean · RBC Units

Total Number of RBCs Used Over Admission
RBC Units	Patients Given Traditional Cryo	Patients Given PR Cryo
Total Number of RBCs Used Over Admission	5.8 ± 6.5	6.7 ± 7.2

PrimaryTotal Number of Platelets Used Over Admission

Plts used over admission

Time frame:: Within the first 30 days after surgery.
Reported as:: Mean · platelet units

Total Number of Platelets Used Over Admission
platelet units	Patients Given Traditional Cryo	Patients Given PR Cryo
Total Number of Platelets Used Over Admission	2.1 ± 3.1	2.1 ± 2.0

PrimaryTotal Number of Plasma Used Over Admission

All units over admission

Time frame:: Within the first 30 days after surgery.
Reported as:: Mean · plasma units

Total Number of Plasma Used Over Admission
plasma units	Patients Given Traditional Cryo	Patients Given PR Cryo
Total Number of Plasma Used Over Admission	2.7 ± 4.6	3.4 ± 6.0

SecondaryNumber of Cryo Units Used Perioperatively

All products within 3 days

Time frame:: 3 days post procedure
Reported as:: Mean · cryo units

Number of Cryo Units Used Perioperatively
cryo units	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Cryo Units Used Perioperatively	2.3 ± 1.7	2.3 ± 1.6

SecondaryNumber of RBCs Used Perioperatively

Number of RBC units transfused during perioperative period

Time frame:: 3 days post procedure
Reported as:: Mean · RBC units

Number of RBCs Used Perioperatively
RBC units	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of RBCs Used Perioperatively	4.6 ± 5.6	5.9 ± 6.6

SecondaryNumber of Plasma Used Perioperatively

Time frame:: 3 days post procedure
Reported as:: Mean · plasma units

Number of Plasma Used Perioperatively
plasma units	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Plasma Used Perioperatively	2.6 ± 4.6	3.4 ± 6.01

SecondaryNumber of Platelets Used Perioperatively

Number of platelet units transfused during perioperative period

Time frame:: 3 days post procedure
Reported as:: Mean · platelet units

Number of Platelets Used Perioperatively
platelet units	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Platelets Used Perioperatively	1.8 ± 1.7	2.0 ± 1.8

SecondaryTime From Operating Room (OR) Start Time to Start of Cryo Transfusion

Time frame:: procedure (Time from OR start time to start of cryo transfusion)
Reported as:: Median · minutes

Time From Operating Room (OR) Start Time to Start of Cryo Transfusion
minutes	Patients Given Traditional Cryo	Patients Given PR Cryo
Time From Operating Room (OR) Start Time to Start of Cryo Transfusion	366 (309 to 425)	367 (324 to 416)

SecondaryTime From Cryo Order to Start of Transfusion

Time to cryo order time to start of cryo transfusion

Time frame:: procedure (Time from cryo order to start of transfusion)
Reported as:: Mean · minutes

Time From Cryo Order to Start of Transfusion
minutes	Patients Given Traditional Cryo	Patients Given PR Cryo
Time From Cryo Order to Start of Transfusion	128.3 ± 200.7	88.5 ± 99.8

SecondaryNumber of Cryo Units Wasted by Blood Bank

This captures the Cryoprecipitate units discarded.

Time frame:: Daily, up to approximately 24 months

No measurements were reported for this outcome.

SecondaryPre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation

FIBTEM before transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.

Time frame:: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Reported as:: Mean · mm

Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation
mm	Patients Given Traditional Cryo	Patients Given PR Cryo
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation	9.6 ± 6.8	8.3 ± 4.2

SecondaryPost Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation

FIBTEM after transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.

Time frame:: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.

No measurements were reported for this outcome.

SecondaryMaximum Clot Firmness (MCF)

The maximum strength of a clot as determined by ROTEM testing.

Time frame:: Variable, but it is generally available within 1 hour of the start of ROTEM testing.

No measurements were reported for this outcome.

SecondaryPre-transfusion Fibrinogen Level

The fibrinogen measurement before cryoprecipitate is transfused.

Time frame:: During surgery, within 3 hours of specimen receipt by laboratory.
Reported as:: Mean · mg/dL

Pre-transfusion Fibrinogen Level
mg/dL	Patients Given Traditional Cryo	Patients Given PR Cryo
Pre-transfusion Fibrinogen Level	145 ± 68	191 ± 33

SecondaryHighest Fibrinogen Level Within 24 Hours

Time frame:: Within 24 hours after surgery
Reported as:: Mean · mg/dL

Highest Fibrinogen Level Within 24 Hours
mg/dL	Patients Given Traditional Cryo	Patients Given PR Cryo
Highest Fibrinogen Level Within 24 Hours	210 ± 53	212 ± 46

SecondaryLowest Fibrinogen Level Within 24 Hours

Time frame:: Within 24 hours after surgery
Reported as:: Mean · mg/dL

Lowest Fibrinogen Level Within 24 Hours
mg/dL	Patients Given Traditional Cryo	Patients Given PR Cryo
Lowest Fibrinogen Level Within 24 Hours	194.5 ± 51.0	199.89 ± 44.3

SecondaryCumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal

The cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of drain removal

Time frame:: Up to approximately 3 days

No measurements were reported for this outcome.

SecondaryVolume in Drains (Chest Tube for CV Surgery)

Time frame:: At 24 hours after surgery
Reported as:: Mean · mLs

Volume in Drains (Chest Tube for CV Surgery)
mLs	Patients Given Traditional Cryo	Patients Given PR Cryo
Volume in Drains (Chest Tube for CV Surgery)	897 ± 810	749 ± 496

SecondaryTime From End of Bypass Pump for CV Surgery

Time frame:: Until end of surgery
Reported as:: Median · hours

Time From End of Bypass Pump for CV Surgery
hours	Patients Given Traditional Cryo	Patients Given PR Cryo
Time From End of Bypass Pump for CV Surgery	2.75 (2.32 to 3.27)	2.73 (2.46 to 3.22)

SecondaryLength of Stay in OR

Operating room length of stay

Time frame:: Duration of time in operating room
Reported as:: Mean · minutes

Length of Stay in OR
minutes	Patients Given Traditional Cryo	Patients Given PR Cryo
Length of Stay in OR	522 ± 124	534 ± 118

SecondaryLength of Stay in ICU

Participant length of stay in ICU setting

Time frame:: During hospitalization, approximately 5 days to 30 days
Reported as:: Mean · days

Length of Stay in ICU
days	Patients Given Traditional Cryo	Patients Given PR Cryo
Length of Stay in ICU	8.1 ± 11.8	6.9 ± 8.6

SecondaryLength of Stay in Hospital

Overall length of stay in hospital

Time frame:: During hospitalization, approximately 5 days to 30 days
Reported as:: Mean · days

Length of Stay in Hospital
days	Patients Given Traditional Cryo	Patients Given PR Cryo
Length of Stay in Hospital	12.0 ± 9.4	10.9 ± 10.1

SecondaryNeed for Ventilator

Time frame:: During hospitalization, approximately 5 days to 30 days
Reported as:: Count of participants · Participants

Need for Ventilator
Participants	Patients Given Traditional Cryo	Patients Given PR Cryo
Need for Ventilator	99	96

SecondaryTime on Ventilator

If participant was on ventilator, amount of time spent on ventilator

Time frame:: During hospitalization, approximately 5 days to 30 days
Reported as:: Mean · days

Time on Ventilator
days	Patients Given Traditional Cryo	Patients Given PR Cryo
Time on Ventilator	2.4 ± 4.9	2.6 ± 6.3

SecondaryOverall Cost of Cryo vs PR Cryo, When Factoring Wastage

Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.

Time frame:: Daily, approximately 24 months

No measurements were reported for this outcome.

SecondaryNumber of Participants That Experienced an Adverse Event of Fever

All participants that experience fevers that occur during the time frame

Time frame:: Within 5 days of surgery start time
Reported as:: Count of participants · Participants

Number of Participants That Experienced an Adverse Event of Fever
Participants	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Participants That Experienced an Adverse Event of Fever	16	14

SecondaryNumber of Participants That Experienced an Adverse Event of Infection

All participants that experience infections that occur during the time frame

Time frame:: Within 5 days of surgery start time
Reported as:: Count of participants · Participants

Number of Participants That Experienced an Adverse Event of Infection
Participants	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Participants That Experienced an Adverse Event of Infection	6	4

SecondaryNumber of Participants That Experienced an Adverse Event of Transfusion Reaction.

All participants that experience transfusion reactions that occur during the time frame

Time frame:: Within 5 days of surgery start time
Reported as:: Count of participants · Participants

Number of Participants That Experienced an Adverse Event of Transfusion Reaction.
Participants	Patients Given Traditional Cryo	Patients Given PR Cryo
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.	0	0

SecondaryFibrinogen Level

Fibrinogen level most proximal to the end of surgery

Time frame:: Most proximal to end of procedure
Reported as:: Mean · mg/dL

Fibrinogen Level
mg/dL	Patients Given Traditional Cryo	Patients Given PR Cryo
Fibrinogen Level	197 ± 52	201 ± 38

Adverse events

Collected over Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Patients Given Traditional Cryo	5/105 (4.8%)	0/105 (0%)	18/105 (17.1%)
Patients Given PR Cryo	2/103 (1.9%)	0/103 (0%)	17/103 (16.5%)

Most frequent serious events

Most frequent serious events
Event	Patients Given Traditional Cryo	Patients Given PR Cryo
Transfusion ReactionsBlood and lymphatic system disorders	0/105	0/103

Most frequent other events

Most frequent other events
Event	Patients Given Traditional Cryo	Patients Given PR Cryo
FeverInfections and infestations	16/105	14/103
InfectionInfections and infestations	6/105	4/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Patients Given Traditional Cryo	Patients Given PR Cryo	Total
Mean	62 ± 14	61 ± 14	61 ± 14

Sex: Female, Male
Sex: Female, Male(Participants)	Patients Given Traditional Cryo	Patients Given PR Cryo	Total
Female	39	41	80
Male	66	62	128

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Patients Given Traditional Cryo	Patients Given PR Cryo	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	14	1	15
Unknown or Not Reported	91	102	193

Region of Enrollment
Region of Enrollment(participants)	Patients Given Traditional Cryo	Patients Given PR Cryo	Total
United States	105	103	208

ASA Score
ASA Score(Score on a scale)	Patients Given Traditional Cryo	Patients Given PR Cryo	Total
Mean	3.8 ± 0.51	3.8 ± 0.43	3.8 ± 0.47

Study locations

1 site

New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York 10065, United States

References and documents

Publications

Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol. 2016 Jun;74:40-50. doi: 10.1016/j.jclinepi.2015.11.013. Epub 2015 Nov 26. PubMed 26633599 ↗
Saland LC. Effects of reserpine administration on the fine structure of the rat pars intermedia. Cell Tissue Res. 1978 Nov 9;194(1):115-23. doi: 10.1007/BF00209237. PubMed 719724 ↗
Cushing MM, Fitzgerald MM, Harris RM, Asmis LM, Haas T. Influence of cryoprecipitate, Factor XIII, and fibrinogen concentrate on hyperfibrinolysis. Transfusion. 2017 Oct;57(10):2502-2510. doi: 10.1111/trf.14259. Epub 2017 Jul 21. PubMed 28734018 ↗
Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1. PubMed 32478877 ↗
Fenderson JL, Meledeo MA, Rendo MJ, Peltier GC, McIntosh CS, Davis KW, Corley JB, Cap AP. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Transfusion. 2019 Apr;59(S2):1560-1567. doi: 10.1111/trf.15180. PubMed 30980741 ↗
Bulkley GB, Wheaton LG, Strandberg JD, Zuidema GD. Assessment of small intestinal recovery from ischemic injury after segmental, arterial, venous, and arteriovenous occlusion. Surg Forum. 1979;30:210-3. No abstract available. PubMed 538597 ↗
Hsien S, Dayton JD, Chen D, Stock A, Bacha E, Cushing MM, Nellis ME. Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass. Transfusion. 2022 Feb;62(2):298-305. doi: 10.1111/trf.16768. Epub 2021 Dec 13. PubMed 34904250 ↗
Lokhandwala PM, O'Neal A, Patel EU, Brunker PAR, Gehrie EA, Zheng G, Kickler TS, Ness PM, Tobian AAR. Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing. Transfusion. 2018 May;58(5):1126-1131. doi: 10.1111/trf.14550. Epub 2018 Feb 25. PubMed 29479708 ↗
Thomson C, Sobieraj-Teague M, Scott D, Duncan E, Abraham S, Roxby D. Extending the post-thaw viability of cryoprecipitate. Transfusion. 2021 May;61(5):1578-1585. doi: 10.1111/trf.16366. Epub 2021 Mar 17. PubMed 33728705 ↗
Cushing MM, Cohen T, Fitzgerald MM, Rand S, Sinfort A, Chen D, Keltner N, Ong S, Parra P, Benabdessadek D, Jimenez A, Haas T, Lau C, Girardi NI, DeSimone RA. Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial. Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x. PubMed 39334317 ↗

Study documents

Protocol and statistical analysis plan · Jan 24, 2023

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

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05711524
Lead sponsor: Weill Medical College of Cornell University
Collaborators: Cerus Corporation
Responsible party: Sponsor
First posted: Feb 3, 2023
Start date: Apr 1, 2023
Primary completion: Oct 23, 2024
Completion: Oct 3, 2025
Results posted: Nov 21, 2025
Last update: Nov 21, 2025

Study contacts

Melissa Cushing

principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

Study summary

Conditions studied

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Keywords

In context

Hemorrhage

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

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Oversight

Not currently enrolling

Follow this study

Discussion

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Inclusion criteria

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