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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: desmopressin


Participation Criteria
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Eligibility Criteria
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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 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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin<br>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 | Drug: desmopressin<br>* 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision<br>* Other names: DDAVP;|
| Placebo Comparator: placebo<br>100 of saline labeled as study drug administered in 30 minutes a half hour before surgical incision | Drug: desmopressin<br>* 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision<br>* Other names: DDAVP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Blood loss obtained from fluid balance of surgery plus drain output | once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acquired von Willebrand disease, severe aortic stenosis, Heye´s syndrome, desmopressin, von Willebrand multimers