Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Desmopressin.

Some patients undergoing cardiac surgery develop excessive postoperative bleeding.

Cardiopulmonary bypass causes platelet dysfunction.

It had two arms (groups): Active treatment (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

17 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients above 18 years of age scheduled for cardiac surgery.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

The Desmopressin group and the comparison group ran side by side rather than switching.

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-03 with completion listed for 2012-02.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Transfusion of blood components (time frame: During postoperative stay).

It also tracked 3 secondary outcomes, for example Postoperative hemorrhage, Platelet activation and Activation of coagulation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 17 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.