Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery

What Was Tested

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

Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.

It had two arms (groups): Desmopressin (experimental) and placebo (placebo comparator).

100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision.

The registry classes the interventions as drug.

More on the Plan

Randomized Controlled trial compared with placebo in a double blind fashion.

Blood loss, postoperative hematocrit and transfusion requirement were measured, plasma sodium was measured as a safety issue.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Severe aortic stenosis defined as mean transvalvular gradient greater or equal to 40 mmHg ot transvalvular area less than 1 cm2. Scheduled for aortic valve replacement surgery.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: combined surgery (plus coronary artery bypass graft or other valve replacement/plasty); infective endocarditis; previously known haemostatic disorder.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

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, investigator and outcomes assessor.

It started in 2009-06 with completion listed for 2009-12.

It ran at 1 site in Chile.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: blood loss (time frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration).

It also tracked 2 secondary outcomes, for example postoperative hematocrit and need of transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 13 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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