DRUG
desmopressin
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Status
Completed
Phase
Phase 4
Enrollment
13
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Nov 25, 2013
Study start
Jun 2009
Primary completion
Dec 2009
Study completion
Feb 2010
Results posted
Not reported
Registry updated
Apr 5, 2017
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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)
Study locations
1 registered sites.
Chile. Showing up to 24 locations stored in the fast local snapshot.
Hospital Clínico Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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