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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Pontificia Universidad Catolica de Chile

Current Primary Outcome: blood loss [ Time Frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration ]

Blood loss obtained from fluid balance of surgery plus drain output


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • postoperative hematocrit [ Time Frame: the morning after surgery (18-24 hours after drug administration) ]
    hematocrit and hemoglobin in time frame mentioned
  • need of transfusion [ Time Frame: 48 hours post administration ]
    transfusion of packaged red cells units until 48 hours after administration of study drug


Original Secondary Outcome: Same as current

Information By: Pontificia Universidad Catolica de Chile

Dates:
Date Received: November 14, 2013
Date Started: June 2009
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017