Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885924
Recruitment Status : Terminated (to include required number of patients took too much time)
First Posted : April 22, 2009
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Postoperative Blood Loss Drug: Desmopressin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
Study Start Date : March 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active treatment
Desmopressin 0.3 microgram/kg
Drug: Desmopressin
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
Other Name: Octostim, Ferring ATC-nr.:H01B A02
Placebo Comparator: Placebo
NaCl 0.9%
Drug: Placebo
NaCl 0.9%

Primary Outcome Measures :
  1. Transfusion of blood components [ Time Frame: During postoperative stay ]

Secondary Outcome Measures :
  1. Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ]
  2. Platelet activation [ Time Frame: 20 hours postoperatively ]
  3. Activation of coagulation [ Time Frame: 20 hours postoperatively ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885924

StOlavs Hopital
Trondheim, Norway, 7018
Sponsors and Collaborators
St. Olavs Hospital
Principal Investigator: Guri Greiff, MD StOalvs Hospital

Responsible Party: St. Olavs Hospital Identifier: NCT00885924     History of Changes
Other Study ID Numbers: 4.2008.947
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by St. Olavs Hospital:
postoperative Hemorrhage
Blood Loss, Surgical

Additional relevant MeSH terms:
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs