Clinical trial NCT00885924: Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
Official title: Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemorrhage
Postoperative Blood Loss
Keywords: postoperative Hemorrhage
Hemorrhage
Vasopressin
Blood Loss, Surgical
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Transfusion of blood components
timeFrame: During postoperative stay
Secondary outcomes:
measure: Postoperative hemorrhage
timeFrame: First 16 hours postoperatively
measure: Platelet activation
timeFrame: 20 hours postoperatively
measure: Activation of coagulation
timeFrame: 20 hours postoperatively
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: StOlavs Hopital
Study officials:
affiliation: StOalvs Hospital
name: Guri Greiff, MD
role: PRINCIPAL_INVESTIGATOR
References: