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Last Updated: March 3, 2021

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CLINICAL TRIALS PROFILE FOR THROMBATE III

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All Clinical Trials for THROMBATE III

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01698567 Antithrombin III in Infants With Cardiopulmonary Bypass (CPB) Terminated University of Rochester Phase 1 2012-07-01 The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
NCT04376762 Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients Not yet recruiting Octapharma Phase 4 2020-09-01 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, patients 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 patients (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). Future plans are to conduct a large multi-center, randomized active-control non-inferiority trial 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.
NCT04376762 Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients Not yet recruiting University of Virginia Phase 4 2020-09-01 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, patients 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 patients (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). Future plans are to conduct a large multi-center, randomized active-control non-inferiority trial 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for THROMBATE III

Condition Name

Condition Name for THROMBATE III
Intervention Trials
Pediatric HD 1
Congenital Heart Disease 1
Bleeding 1
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Condition MeSH

Condition MeSH for THROMBATE III
Intervention Trials
Heart Diseases 1
Heart Defects, Congenital 1
Hemorrhage 1
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Clinical Trial Locations for THROMBATE III

Trials by Country

Trials by Country for THROMBATE III
Location Trials
United States 2
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Trials by US State

Trials by US State for THROMBATE III
Location Trials
Virginia 1
New York 1
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Clinical Trial Progress for THROMBATE III

Clinical Trial Phase

Clinical Trial Phase for THROMBATE III
Clinical Trial Phase Trials
Phase 4 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for THROMBATE III
Clinical Trial Phase Trials
Not yet recruiting 1
Terminated 1
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Clinical Trial Sponsors for THROMBATE III

Sponsor Name

Sponsor Name for THROMBATE III
Sponsor Trials
Octapharma 1
University of Rochester 1
University of Virginia 1
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Sponsor Type

Sponsor Type for THROMBATE III
Sponsor Trials
Other 2
Industry 1
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Serving leading biopharmaceutical companies globally:

McKesson
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Express Scripts
Dow

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