Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Conditions
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Hemorrhage, Postoperative Blood Loss

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment<br>Desmopressin 0.3 microgram/kg | Drug: Desmopressin<br>* Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.<br>* Other names: Octostim, Ferring ATC-nr.:H01B A02;|
| Placebo Comparator: Placebo<br>NaCl 0.9% | Drug: Placebo<br>* NaCl 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion of blood components |  | During postoperative stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hemorrhage |  | First 16 hours postoperatively | 
| Platelet activation |  | 20 hours postoperatively | 
| Activation of coagulation |  | 20 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative Hemorrhage, Hemorrhage, Vasopressin, Blood Loss, Surgical