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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Completed

CT.gov ID

NCT01994330

Collaborator

Ferring Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis Heye´s Syndrome Severe Aortic Stenosis	Drug: desmopressin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desmopressin 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 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision Other Names: DDAVP
Placebo Comparator: placebo 100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision	Drug: desmopressin 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision Other Names: DDAVP

Arm

Intervention/Treatment

Experimental: Desmopressin

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

0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision

Other Names:

DDAVP

Placebo Comparator: placebo

100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision

Drug: desmopressin

0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision

Other Names:

DDAVP

Outcome Measures

Primary Outcome Measures

blood loss [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 Outcome Measures

postoperative hematocrit [the morning after surgery (18-24 hours after drug administration)]
hematocrit and hemoglobin in time frame mentioned
need of transfusion [48 hours post administration]
transfusion of packaged red cells units until 48 hours after administration of study drug

Other Outcome Measures

incidence of hyponatremia [18-24 hours post administration of study drug]
blood sampling for plasma sodium in specified time frame
von Willebrand study and protein electrophoresis [the day of surgery, half hour previous to administration of study drug]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico Universidad Católica de Chile	Santiago	Region Metropolitana	Chile

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile
Ferring Pharmaceuticals

Investigators

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