You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR FIBRINOGEN HUMAN AND THROMBIN HUMAN


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for fibrinogen human and thrombin human

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00113997 ↗ Safety and Dosing Evaluation of REG1 Anticoagulation System Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2005-06-01 This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." Patients with heart attack and other conditions require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine in normal healthy subjects how the REG1 system works in the body and how it leaves the body. Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264 pounds) and have no history of bleeding problems or significant bleeding may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants must avoid foods that may alter the blood's clotting ability and must not take any medications the week of the study. They undergo the following tests and procedures: Day 1 Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample. Day 2 A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples. Days 3 and 7 A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.
NCT00174902 ↗ The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress Unknown status Swiss National Science Foundation Phase 1/Phase 2 2003-10-01 This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.
NCT00174902 ↗ The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress Unknown status Swiss Federal Institute of Technology Phase 1/Phase 2 2003-10-01 This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.
NCT00181974 ↗ Efficacy of a Fibrin Sealant in Burn Surgery Completed Shriners Hospitals for Children N/A 2000-03-01 The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.
NCT00181974 ↗ Efficacy of a Fibrin Sealant in Burn Surgery Completed Massachusetts General Hospital N/A 2000-03-01 The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.
NCT00440921 ↗ Clinical Trial for Fibrin Sealant in Knee Surgery Withdrawn MDM N/A 2008-12-01 - 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 2008-12-01 - 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for fibrinogen human and thrombin human

Condition Name

Condition Name for fibrinogen human and thrombin human
Intervention Trials
Breast Cancer 2
Atrial Fibrillation 2
Healthy 2
Bleeding 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for fibrinogen human and thrombin human
Intervention Trials
Atrial Fibrillation 4
Hemorrhage 3
Heart Diseases 3
Coronary Artery Disease 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for fibrinogen human and thrombin human

Trials by Country

Trials by Country for fibrinogen human and thrombin human
Location Trials
United States 13
Poland 4
Italy 4
Netherlands 3
Germany 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for fibrinogen human and thrombin human
Location Trials
Maryland 4
Pennsylvania 2
Illinois 1
New York 1
Utah 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for fibrinogen human and thrombin human

Clinical Trial Phase

Clinical Trial Phase for fibrinogen human and thrombin human
Clinical Trial Phase Trials
Phase 4 10
Phase 3 9
Phase 2/Phase 3 2
[disabled in preview] 18
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for fibrinogen human and thrombin human
Clinical Trial Phase Trials
Completed 25
Unknown status 6
Recruiting 5
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for fibrinogen human and thrombin human

Sponsor Name

Sponsor Name for fibrinogen human and thrombin human
Sponsor Trials
CSL Behring 3
IRCCS Policlinico S. Donato 2
University of Sao Paulo 2
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for fibrinogen human and thrombin human
Sponsor Trials
Other 56
Industry 13
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.