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Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Primary Purpose

Hemorrhage, Postoperative Blood Loss

Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Desmopressin
Placebo
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring postoperative Hemorrhage, Hemorrhage, Vasopressin, Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • StOlavs Hopital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active treatment

Placebo

Arm Description

Desmopressin 0.3 microgram/kg

NaCl 0.9%

Outcomes

Primary Outcome Measures

Transfusion of blood components

Secondary Outcome Measures

Postoperative hemorrhage
Platelet activation
Activation of coagulation

Full Information

First Posted
April 2, 2009
Last Updated
April 7, 2015
Sponsor
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00885924
Brief Title
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
Official Title
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
to include required number of patients took too much time
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Postoperative Blood Loss
Keywords
postoperative Hemorrhage, Hemorrhage, Vasopressin, Blood Loss, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Desmopressin 0.3 microgram/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9%
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Octostim, Ferring ATC-nr.:H01B A02
Intervention Description
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl 0.9%
Primary Outcome Measure Information:
Title
Transfusion of blood components
Time Frame
During postoperative stay
Secondary Outcome Measure Information:
Title
Postoperative hemorrhage
Time Frame
First 16 hours postoperatively
Title
Platelet activation
Time Frame
20 hours postoperatively
Title
Activation of coagulation
Time Frame
20 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guri Greiff, MD
Organizational Affiliation
StOalvs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
StOlavs Hopital
City
Trondheim
ZIP/Postal Code
7018
Country
Norway

12. IPD Sharing Statement

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Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

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