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

Phase 4

Completed

• Conditions: Heye´s Syndrome; Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis; Severe Aortic Stenosis
• Interventions: Drug: desmopressin

• Registration Number: NCT01994330
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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

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Exclusion Criteria

• combined surgery (plus coronary artery bypass graft or other valve replacement/plasty)
• Infective Endocarditis
• previously known haemostatic disorder
• previous treatment with oral anticoagulants or IIb-IIIa inhibitors (we did not exclude those on acetyl-salicylic acid)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desmopressin	desmopressin	0,3 mcg per kilogram of desmopressin in 100 ml of saline, labeled as "study drug" and administered in 30 minutes a half hour before surgical incision
placebo	desmopressin	100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision

Primary Outcome Measures

Name	Time	Method
blood loss	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínico Universidad Católica de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile