Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Information source: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis; Heye´s Syndrome; Severe Aortic Stenosis
Intervention: desmopressin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pontificia Universidad Catolica de Chile Official(s) and/or principal investigator(s): esperanza carrasco, anesthesiologist, Principal Investigator, Affiliation: Pontificia Universidad Catolica de Chile rodrigo lopez, anesthesiologist, Study Director, Affiliation: Pontificia Universidad Catolica de Chile guillermo lema, profesor titular, Study Chair, Affiliation: Pontificia Universidad Catolica de Chile
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
Clinical Details
Official title: Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: blood loss
Secondary outcome: postoperative hematocritneed of transfusion
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hospital ClÃnico Universidad Católica de Chile, Santiago, Region Metropolitana, Chile
Additional Information
Starting date: June 2009
Last updated: November 19, 2013
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