Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

This study has been terminated.
(to include required number of patients took too much time)
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00885924
First received: April 2, 2009
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Hemorrhage
Postoperative Blood Loss
Drug: Desmopressin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Transfusion of blood components [ Time Frame: During postoperative stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ] [ Designated as safety issue: No ]
  • Platelet activation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
  • Activation of coagulation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885924

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

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00885924     History of Changes
Other Study ID Numbers: 4.2008.947
Study First Received: April 2, 2009
Last Updated: March 5, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 25, 2014