Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Hemorrhage Clinical Trial

Official title:

Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00885924
• Other study ID #: 4.2008.947
• Status: Terminated
• Phase: Phase 4
• First received: April 2, 2009
• Last updated: April 7, 2015
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Blood Loss
• Postoperative Hemorrhage

Intervention

Drug:
• Desmopressin
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
• Placebo
NaCl 0.9%

Locations

Country	Name	City	State
Norway	StOlavs Hopital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion of blood components		During postoperative stay	No
Secondary	Postoperative hemorrhage		First 16 hours postoperatively	No
Secondary	Platelet activation		20 hours postoperatively	No
Secondary	Activation of coagulation		20 hours postoperatively	No