Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
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
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
Severe Aortic Stenosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery|
- blood loss [ Time Frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration ] [ Designated as safety issue: No ]Blood loss obtained from fluid balance of surgery plus drain output
- postoperative hematocrit [ Time Frame: the morning after surgery (18-24 hours after drug administration) ] [ Designated as safety issue: No ]hematocrit and hemoglobin in time frame mentioned
- need of transfusion [ Time Frame: 48 hours post administration ] [ Designated as safety issue: No ]transfusion of packaged red cells units until 48 hours after administration of study drug
- incidence of hyponatremia [ Time Frame: 18-24 hours post administration of study drug ] [ Designated as safety issue: Yes ]blood sampling for plasma sodium in specified time frame
- von Willebrand study and protein electrophoresis [ Time Frame: the day of surgery, half hour previos to administration of study drug ] [ Designated as safety issue: No ]
blood sampling for von Willebrand study:
- collagen binding activity
- ristocetin factor test
- coagulation factor VIII activity
- von Willebrand factor antigen
- Ristocetin cofactor test/von Willebrand factor antigen ratio and protein electrophoresis of von Willebrand multimers
|Study Start Date:||June 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Other Name: DDAVP
Placebo Comparator: placebo
100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994330
|Hospital Clínico Universidad Católica de Chile|
|Santiago, Region Metropolitana, Chile|
|Principal Investigator:||esperanza carrasco, anesthesiologist||Pontificia Universidad Catolica de Chile|
|Study Director:||rodrigo lopez, anesthesiologist||Pontificia Universidad Catolica de Chile|
|Study Chair:||guillermo lema, profesor titular||Pontificia Universidad Catolica de Chile|