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This is the category page. Below are all of the research programs that are associated with it
- Blood Clotting -
AN OPEN LABEL, RANDOMIZED, MULTICENTER, PHASE IIIB STUDY TO ASSESS THE EFFICACY , SAFETY, AND TOLERANCE OF BERIPLEX® P/N COMPARED WITH PLASMA FOR THE RAPID REVERSAL OF COAGULOPATHY INDUCED BY COUMARIN DERIVATIVES IN SUBJECTS REQUIRING EMERGENCY SURGERY OR INVASIVE INTERVENTION (BE1116_3003)(Protocol #2007-007862-39)
(2_20081204_118)
This study is for patients receiving either an emergency surgical procedure or invasive intervention that are receiving anticoagulation therapy such as warfarin, acenocoumarol or phenprocoumon and will be randomized to receive either Beriplex PN or plasma. Participants will be monitored using INR blood levels at various time points and will be monitored for side effects and exposure of infectious diseases.
- Family present during trauma-
ANXIETY, SATISFACTION WITH NEEDS MET AND WELL-BEING IN FAMILY MEMBERS PRESENT DURING TRAUMA RESUSCITATION: A COMPARATIVE STUDY (Investigator Initiated Protocol)
(2_20081101_118)
Family members of patients admitted to the TNICU will be asked to complete questionnaires about the stress of their loved ones injuries and hospitalization. Responses will be grouped into two categories, families present in the emergency room with the patient; and families that were not present in the emergency room.
- Major Bleeding Problem -
AN OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE IIIB STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERANCE OF BERIPLEX® P/N COMPARED WITH PLASMA FOR RAPID REVERSAL OF COAGULOPATHY INDUCED BY COUMARIN DERIVATIVES IN SUBJECTS WITH ACUTE MAJOR BLEEDING (PROTOCOL BERIPLEX ® P/N (BE 1116)
(2_20080601_118)
This study is for patients who present with acute major bleeding who have an acquired deficiency of coagulation factors II, VII, IX and X and proteins C and S from oral anticoagulation with coumarin derivatives (warfarin, acenocoumarol and phenprocoumon). Participants will be randomized to receive either the study drug, Beriplex® P/N 500 or plasma (standard of care). In addition, all participants will receive vitamin K by slow intravenous infusion. Each participant will participate in this study for a total of 45 days. Over the course of the study participants will have several blood samples taken for testing.
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