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Sponsored by: |
St. Olavs Hospital |
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Information provided by: | St. Olavs Hospital |
ClinicalTrials.gov Identifier: | NCT00885924 |
Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.
Condition | Intervention | Phase |
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Hemorrhage Postoperative Blood Loss |
Drug: Desmopressin Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active treatment: Active Comparator
Desmopressin 0.3 microgram/kg
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Drug: Desmopressin
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
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Placebo: Placebo Comparator
NaCl 0.9%
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Drug: Placebo
NaCl 0.9%
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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:
Norway | |
StOlavs Hopital | Recruiting |
Trondheim, Norway, 7018 | |
Contact: Guri Greiff, MD 004773867000 guri.greiff@stolav.no | |
Contact: Hilde Pleym, MD, PhD 004773867000 hilde.pleym@stolav.no |
Principal Investigator: | Guri Greiff, MD | StOalvs Hospital |
Responsible Party: | St,Olas Hospital ( Mrs. Nina Slind ) |
Study ID Numbers: | 4.2008.947 |
Study First Received: | April 2, 2009 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00885924 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services |
postoperative Hemorrhage Hemorrhage Vasopressin Blood Loss, Surgical |
Arginine Vasopressin Postoperative Complications Arginine Deamino Arginine Vasopressin Vasopressins |
Postoperative Hemorrhage Blood Loss, Surgical Cardiovascular Agents Hemorrhage Hemostatics |
Coagulants Physiological Effects of Drugs Hematologic Agents Postoperative Hemorrhage Cardiovascular Agents Hemorrhage Pharmacologic Actions |
Hemostatics Pathologic Processes Postoperative Complications Natriuretic Agents Deamino Arginine Vasopressin Therapeutic Uses Antidiuretic Agents |