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Sponsored by: |
Heinrich-Heine University, Duesseldorf |
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Information provided by: | Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT00618293 |
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
Condition | Intervention | Phase |
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Blood Loss, Surgical |
Drug: Haemate HS Other: NaCl-solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis) |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
intravenous infusion of Haemate (dosage dependent on body weight)
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Drug: Haemate HS
intravenous infusion of Haemate (dosage dependent on body weight)
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2: Placebo Comparator
intravenous infusion of 0.9% NaCl solution
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Other: NaCl-solution
intravenous infusion of 0.9%NaCl-Solution
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rainer Zotz, PD Dr. | 0049-2118117237 | zotz@med.uni-duesseldorf.de |
Germany, NW | |
Heinrich-Heine University University Hospital Department of Thoracic and Cardiovascular Surgery | Recruiting |
Duesseldorf, NW, Germany, 40225 | |
Contact: P. Feindt, Prof. Dr. 0049-211-8118879 peter.feindt@uni-duesseldorf.de | |
Sub-Investigator: P. Feindt, Prof. Dr. | |
Sub-Investigator: U. Boecken, PD Dr. |
Principal Investigator: | Rainer Zotz, PD Dr. | Institute of Hemostasis and Transfusion Medicine |
Responsible Party: | Department of Hemostasis and Transfusion Medicine ( Heinrich-Heine University, represented by Principal investigator PD Dr. Rainer Zotz ) |
Study ID Numbers: | BI8021_5101 |
Study First Received: | February 8, 2008 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00618293 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
intraoperative bleeding aortic-valve replacement aortic stenosis Von Willebrand HEAMATE |
Heart Diseases Constriction, Pathologic Blood Loss, Surgical Intraoperative Complications |
Hemorrhage Aortic Valve Stenosis Heart Valve Diseases |
Pathologic Processes Heart Diseases Cardiovascular Diseases Blood Loss, Surgical Intraoperative Complications |
Hemorrhage Aortic Valve Stenosis Ventricular Outflow Obstruction Heart Valve Diseases |