Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Phase 4

Terminated

• Conditions: Hemorrhage; Postoperative Blood Loss
• Interventions: Drug: Placebo; Drug: Desmopressin

• Registration Number: NCT00885924
• Lead Sponsor: St. Olavs Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	NaCl 0.9%
Active treatment	Desmopressin	Desmopressin 0.3 microgram/kg

Primary Outcome Measures

Name	Time	Method
Transfusion of blood components	During postoperative stay

Secondary Outcome Measures

Name	Time	Method
Postoperative hemorrhage	First 16 hours postoperatively
Platelet activation	20 hours postoperatively
Activation of coagulation	20 hours postoperatively

Trial Locations

Locations (1)

StOlavs Hopital; 🇳🇴 Trondheim, Norway