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TerminatedNCT00885924Updated Apr 8, 2015

Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

A Phase 4 interventional study of Desmopressin and Placebo in Hemorrhage and Postoperative Blood Loss, sponsored by St. Olavs Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by St. Olavs Hospital · Phase 4, Interventional, and Treatment

Why this study was terminated
to include required number of patients took too much time
Phase
Phase 4
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemorrhage
  • Postoperative Blood Loss

Keywords

  • postoperative Hemorrhage
  • Hemorrhage
  • Vasopressin
  • Blood Loss, Surgical
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 17 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    Active treatment

    Desmopressin 0.3 microgram/kg

    Drug: Desmopressin

  • Placebo comparator
    Placebo

    NaCl 0.9%

    Drug: Placebo

Interventions

  • DrugDesmopressin

    Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.

    Also known as: Octostim, Ferring ATC-nr.:H01B A02

  • DrugPlacebo

    NaCl 0.9%

06

What researchers measure

Primary outcomes

  1. Transfusion of blood components

    Time frame: During postoperative stay

Secondary outcomes

  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

07

Study locations

1 site
  • StOlavs Hopital
    Trondheim, 7018, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00885924
Lead sponsor
St. Olavs Hospital
Responsible party
Sponsor
First posted
Apr 22, 2009
Start date
Mar 2009
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Apr 8, 2015

Study contacts

Guri Greiff, MD
principal investigator · StOalvs Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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