Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Hemorrhage Postoperative Blood Loss |
Drug: Desmopressin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery |
- Transfusion of blood components [ Time Frame: During postoperative stay ] [ Designated as safety issue: No ]
- Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ] [ Designated as safety issue: No ]
- Platelet activation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
- Activation of coagulation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| 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 |
|---|---|
|
Active Comparator: Active treatment
Desmopressin 0.3 microgram/kg
|
Drug: Desmopressin
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
Other Name: Octostim, Ferring ATC-nr.:H01B A02
|
|
Placebo Comparator: Placebo
NaCl 0.9%
|
Drug: Placebo
NaCl 0.9%
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients above 18 years of age scheduled for cardiac surgery
- Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours
Exclusion Criteria:
- Patients younger than 18 years of age
- Patients with a medical condition known to influence the hemostatic system
- Patients treated with clopidogrel or systemic steroids during the last week before surgery
- Patients with INR above 1.5
- Patients who are not able to give written informed concent
- Unstable patients who need other transfusion limits than in this study
Contacts and Locations
More Information
No publications provided
| Responsible Party: | St. Olavs Hospital |
| ClinicalTrials.gov Identifier: | NCT00885924 History of Changes |
| Other Study ID Numbers: | 4.2008.947 |
| Study First Received: | April 2, 2009 |
| Last Updated: | March 5, 2012 |
| Health Authority: | Norway: Norwegian Medicines Agency Norway: Norwegian Social Science Data Services |
Keywords provided by St. Olavs Hospital:
|
postoperative Hemorrhage Hemorrhage Vasopressin Blood Loss, Surgical |
Additional relevant MeSH terms:
|
Hemorrhage Postoperative Hemorrhage Pathologic Processes Postoperative Complications Deamino Arginine Vasopressin Antidiuretic Agents Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013