Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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Hemorrhage Postoperative Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active treatment

Desmopressin 0.3 microgram/kg

Group Type ACTIVE_COMPARATOR

Desmopressin

Intervention Type DRUG

Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.

Placebo

NaCl 0.9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl 0.9%

Interventions

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Desmopressin

Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.

Intervention Type DRUG

Placebo

NaCl 0.9%

Intervention Type DRUG

Other Intervention Names

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Octostim, Ferring ATC-nr.:H01B A02

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No