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Last Updated: December 13, 2019

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CLINICAL TRIALS PROFILE FOR CRYOPRECIPITATE

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Clinical Trials for Cryoprecipitate

Trial ID Title Status Sponsor Phase Summary
NCT00214656 "Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery Unknown status Austin Health Phase 3 Aims and Hypotheses: This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery. Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery. The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.
NCT00440921 Clinical Trial for Fibrin Sealant in Knee Surgery Withdrawn MDM N/A - Thermogenesis is a company that sells a machine for the production of fibrin sealant of single donor plasma, the CryoSeal Fibrin Sealant System (CS-1). - Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate is the fraction of human plasma that contains concentrated coagulation factors, such as fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into fibrin, so that a clot will be formed. - Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g. knee- or hip replacement, cosmetical surgery or partial liverresections. - Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1. Within Sanquin there is a question whether fibrin sealant can be produced from the allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied whether allogenous single donor fibrin sealant produced using the CS-1 is effective in wound healing and as consequence of this can be registered as a product of Sanquin. To answer these questions a national working party is formed, working party Fibrin Sealant. - So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro validation has been performed. - The next step will be a study for the in vivo effectiveness of fibrin sealant produced of single donor allogeneic quarantaine plasma using the CS-1. As control patients without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in this study. Probably, three more hospitals will participate. - The use of fibrin sealant will be studied in a prospective randomized trial for patients undergoing knee and hip replacements.
NCT00440921 Clinical Trial for Fibrin Sealant in Knee Surgery Withdrawn Sanquin Research & Blood Bank Divisions N/A - Thermogenesis is a company that sells a machine for the production of fibrin sealant of single donor plasma, the CryoSeal Fibrin Sealant System (CS-1). - Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate is the fraction of human plasma that contains concentrated coagulation factors, such as fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into fibrin, so that a clot will be formed. - Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g. knee- or hip replacement, cosmetical surgery or partial liverresections. - Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1. Within Sanquin there is a question whether fibrin sealant can be produced from the allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied whether allogenous single donor fibrin sealant produced using the CS-1 is effective in wound healing and as consequence of this can be registered as a product of Sanquin. To answer these questions a national working party is formed, working party Fibrin Sealant. - So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro validation has been performed. - The next step will be a study for the in vivo effectiveness of fibrin sealant produced of single donor allogeneic quarantaine plasma using the CS-1. As control patients without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in this study. Probably, three more hospitals will participate. - The use of fibrin sealant will be studied in a prospective randomized trial for patients undergoing knee and hip replacements.
NCT00722436 Tranexamic Acid for Craniofacial Surgery Terminated University of Pittsburgh Phase 4 Surgical procedures for the correction of craniofacial deformities result in unavoidable and significant blood loss in small children and infants. Patients may experience blood losses that exceed one to two blood volumes. In an effort to reduce our transfusion requirements, we have introduced tranexamic acid into our practice. However, the benefit of tranexamic acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial reconstructions will reduce blood loss and allogeneic transfusion requirements. This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid (Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion of 10 mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of the initial dose and will be continued until skin closure. The primary outcome will include the reduction in the total volume of allogeneic erythrocytes, fresh frozen plasma, and cryoprecipitate transfused in the peri operative period (intraoperative and postoperative) and the number of patients that remain transfusion free. Secondary outcomes will include changes in fibrinogen values, TEG, and clinical assessment of the surgical field.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Cryoprecipitate

Condition Name

Condition Name for
Intervention Trials
Coagulopathy 4
Blood Coagulation Disorders 3
Trauma 3
Haemorrhage 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Blood Coagulation Disorders 8
Hemostatic Disorders 8
Hemorrhage 7
Wounds and Injuries 4
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Clinical Trial Locations for Cryoprecipitate

Trials by Country

Trials by Country for
Location Trials
United States 7
Canada 7
Australia 3
Brazil 3
Mexico 1
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Trials by US State

Trials by US State for
Location Trials
Georgia 2
Ohio 1
New York 1
Maryland 1
Virginia 1
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Clinical Trial Progress for Cryoprecipitate

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 5
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 10
Not yet recruiting 5
Completed 4
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Clinical Trial Sponsors for Cryoprecipitate

Sponsor Name

Sponsor Name for
Sponsor Trials
CSL Behring 3
Australian Red Cross 2
Gold Coast Hospital and Health Service 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 32
Industry 6
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