DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 hematocrit

need 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 Clínico Universidad Católica de Chile, Santiago, Region Metropolitana, Chile
Additional Information

Starting date: June 2009
Last updated: November 19, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017