NCT01994330

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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. We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve replacement surgery will reduce blood loss and transfusion rate. this was a pilot study

Detailed description

Randomized Controlled trial compared with placebo in a double blind fashion. Subjects with severe aortic stenosis (transvalvular gradient \>50 mmHg or valvular area of lass than 1 cm2) scheduled for aortic valve replacement were enrolled. the day of surgery blood samples were taken in order to confirm diagnosis (factor VIII activity and Protein electrophoresis for Von Willebrand´s multimers) and then 0,3 mcg/k of DDAVP or saline equally labeled as "study drug" were administered en 30 minutes a half hour before incision. Blood loss, postoperative hematocrit and transfusion requirement were measured, plasma sodium was measured as a safety issue.

Conditions

• Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
• Heye´s Syndrome
• Severe Aortic Stenosis

Interventions

Type	Name	Description
DRUG	desmopressin	0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2013-11-25
• Last updated: 2017-04-05

Locations

1 site across 1 country: Chile