Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery

What Was Tested

The trial (phase 4) is built around Desmopressin.

The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.

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

The registry classes the interventions as drug.

More on the Plan

Patients with important valve disorders may evaluate with coagulopathy induced by mechanical effects (valvular stenosis or valvular insufficiency).

Furthermore, frequently is required prophylactic use of antiplatelet drugs due to myocardial remodeling and antiarrhythmic conditions that may be associated.

Patients with severe aortic stenosis may also acquired von Willebrand disease type 2A due to proteolysis of vonWillebrand factor.

Despite of this, the treatment of valve disorders often requires cardiac surgery with cardiopulmonary bypass.

Who Took Part

108 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Valve cardiac surgery with cardiopulmonary bypass. Written informed consent.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: reoperative valve surgery; body mass index \> 35; antiplatelet administration within 10 days preceding study surgery.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

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

It started in 2015-02 with completion listed for 2017-11.

It ran at 1 site in Brazil.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in coagulation parameters. Postoperative blood loss (time frame: 48 hours).

It also tracked 8 secondary outcomes, for example Blood transfusion, Reoperation for bleeding, Duration of Mechanical ventilation, Length of vasoactive drugs, Length of ICU stay and Clinical complications - renal failure, infection, myocardial ischemia, stroke.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 108 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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