Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

NCTNCT00885924Other id4.2008.947

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: to include required number of patients took too much time

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 17 participants (actual)
Sponsor: St. Olavs Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Norway
Start: Mar 2009
Primary completion: Feb 2012
Completion: Feb 2012
First posted: 22 Apr 2009 (estimated)
Last update posted: 8 Apr 2015 (estimated)
Conditions: Hemorrhage · Postoperative Blood Loss

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 4
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
NCT00885924
Mar 2009 to Feb 2012
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DesmopressinDrug
PlaceboDrug

Arms2

Active comparator
Active treatment
Desmopressin 0.3 microgram/kg
Placebo comparator
Placebo
NaCl 0.9%

Primary outcomes1

Outcomes the sponsor listed as primary.

Transfusion of blood components
Time frame · During postoperative stay

Secondary outcomes(3)

Postoperative hemorrhage
Time frame · First 16 hours postoperatively
Platelet activation
Time frame · 20 hours postoperatively
Activation of coagulation
Time frame · 20 hours postoperatively

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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