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

Severe Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994330
• Other study ID #: RVA
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2013
• Last updated: April 4, 2017
• Start date: June 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2017
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heye´s Syndrome
• Severe Aortic Stenosis
• Von Willebrand Diseases

Intervention

Drug:
• desmopressin
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad Católica de Chile	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Ferring Pharmaceuticals

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of hyponatremia	blood sampling for plasma sodium in specified time frame	18-24 hours post administration of study drug
Other	von Willebrand study and protein electrophoresis	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	the day of surgery, half hour previous to administration of study drug
Primary	blood loss	Blood loss obtained from fluid balance of surgery plus drain output	once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration
Secondary	postoperative hematocrit	hematocrit and hemoglobin in time frame mentioned	the morning after surgery (18-24 hours after drug administration)
Secondary	need of transfusion	transfusion of packaged red cells units until 48 hours after administration of study drug	48 hours post administration