A Phase 4 interventional study of Fibrinogen Concentrate and Cryoprecipitate in Congenital Heart Disease, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions.
Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm.
We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level \<250mg/dL while on bypass.
We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.
Patients under 12 months of age requiring cardiopulmonary bypass surgery will be approached for the study. Patients with a pre- existing coagulopathy, including unexplained bleeding or history of clotting, will be excluded. Prior to the study beginning, patients will be randomized to our standard transfusion algorithm with cryoprecipitate or fibrinogen concentrate. As is standard of care, laboratory tests will be sent at standard times points
For patients randomized to the study arm (fibrinogen concentrate), the fibrinogen level measured on bypass will be used to calculate the appropriate dose of fibrinogen concentrate to achieve a level of 300mg/dL after separation from bypass. Fibrinogen concentrate will replace cryoprecipitate in our post-operative transfusion algorithm. If the patient has continued bleeding based on laboratory values and clinical situation, the patient will be given cryoprecipitate as a rescue measure. Patients not on the study protocol will receive our normal transfusion algorithm.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Biological: Cryoprecipitate
Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group
Biological: Fibrinogen Concentrate
Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group
Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival.
For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.
Time frame: From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours)
Chest Tube Output
Volume of chest tube drainage evaluated over first 24 hours post operatively
Time frame: From administration end of surgery to 24 hours post operatively
Hours of Mechanical Ventilation
Time frame: From administration of the drug during surgery to extubation in the ICU (up to 30 days)
Length of Stay in Intensive Care Unit (ICU)
Time frame: From administration of the drug during surgery to discharge from the ICU (up to 3 months)
Length of Stay in Hospital
Time frame: From administration of the drug during surgery to discharge from the hospital (up to 6 months)
Count of Participants Who Died Within 30 Days Following Procedure
Time frame: From administration of the drug to 30 days following surgery
| Milestone | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Started | 30 | 30 |
| Completed | 25 | 29 |
| Not completed | 5 | 1 |
For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.
| ADT units | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. | 5 (4 to 7) | 4 (3 to 5) |
Volume of chest tube drainage evaluated over first 24 hours post operatively
| ml/kg | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Chest Tube Output | 18.05 (10.94 to 26.03) | 16.11 (12.56 to 25.00) |
| hours | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Hours of Mechanical Ventilation | 30.32 (18.68 to 98.73) | 27.10 (20.42 to 51.58) |
| days | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Length of Stay in Intensive Care Unit (ICU) | 4.50 (2.00 to 6.00) | 3.00 (2.00 to 7.00) |
| days | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Length of Stay in Hospital | 8.00 (5.00 to 19.00) | 7.00 (4.00 to 11.00) |
| Participants | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Count of Participants Who Died Within 30 Days Following Procedure | 0 | 1 |
Collected over Day of procedure through 30 days postoperatively or hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cryoprecipitate Arm | 0/30 (0%) | 2/30 (6.7%) | 8/30 (26.7%) |
| Fibrinogen Concentrate Arm | 1/30 (3.3%) | 4/30 (13.3%) | 5/30 (16.7%) |
| Event | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Chest ExplorationRespiratory, thoracic and mediastinal disorders | 1/30 | 2/30 |
| DeathGeneral disorders | 0/30 | 1/30 |
| StrokeNervous system disorders | 1/30 | 0/30 |
| TamponadeCardiac disorders | 0/30 | 1/30 |
| Thrombosis requiring InterventionVascular disorders | 0/30 | 1/30 |
| Event | Cryoprecipitate Arm | Fibrinogen Concentrate Arm |
|---|---|---|
| Arrhythmia requiring treatmentCardiac disorders | 6/30 | 5/30 |
| Repeat Surgery (less than 7 days)Surgical and medical procedures | 2/30 | 0/30 |
| Infection (with positive culture within 14 days)Infections and infestations | 1/30 | 0/30 |
| Age, Continuous(months) | Cryoprecipitate Arm | Fibrinogen Concentrate Arm | Total |
|---|---|---|---|
| Median | 4 (2 to 5) | 4 (2 to 7) | 4 (2 to 7) |
| Sex: Female, Male(Participants) | Cryoprecipitate Arm | Fibrinogen Concentrate Arm | Total |
|---|---|---|---|
| Female | 16 | 9 | 25 |
| Male | 14 | 21 | 35 |
| Race (NIH/OMB)(Participants) | Cryoprecipitate Arm | Fibrinogen Concentrate Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 22 | 18 | 40 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 4 | 3 | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University