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
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.
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 →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Desmopressin 0.3 microgram/kg
Drug: Desmopressin
NaCl 0.9%
Drug: Placebo
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
Also known as: Octostim, Ferring ATC-nr.:H01B A02
NaCl 0.9%
Transfusion of blood components
Time frame: During postoperative stay
Postoperative hemorrhage
Time frame: First 16 hours postoperatively
Platelet activation
Time frame: 20 hours postoperatively
Activation of coagulation
Time frame: 20 hours postoperatively
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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St. Olavs Hospital