Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
CSL Behring |
---|---|
Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00701142 |
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Condition | Intervention | Phase |
---|---|---|
Aortic Aneurysm |
Biological: Haemocomplettan® P Biological: Saline solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Haemocomplettan® P: Active Comparator
Intravenous infusion during aortic surgery
|
Biological: Haemocomplettan® P
Single intravenous infusion
|
Saline solution: Placebo Comparator |
Biological: Saline solution
Single intravenous infusion
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Central Contact: Clinical Trial Registration Coordinator | clinicaltrials@cslbehring.com |
Germany | |
Medical School Hannover (MHH) | Recruiting |
Hannover, Germany |
Principal Investigator: | Niels Rahe-Meyer, Dr. Dr. | Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover |
Responsible Party: | CSL Behring ( Global Head Clinical Research & Development ) |
Study ID Numbers: | 1470, BI3023_2002 |
Study First Received: | June 16, 2008 |
Last Updated: | July 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00701142 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Aortic Diseases Aneurysm Vascular Diseases Hemorrhage Aortic Aneurysm |
Aortic Diseases Aneurysm Vascular Diseases Cardiovascular Diseases Aortic Aneurysm |