Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

St. Olavs Hospital

Status and phase

Terminated

Phase 4

Conditions

Postoperative Blood Loss

Hemorrhage

Treatments

Drug: Placebo

Drug: Desmopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT00885924

4.2008.947

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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