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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Heye´s Syndrome; Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis; Severe Aortic Stenosis

Treatments: Drug: desmopressin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01994330

RVA

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Desmopressin

Experimental group

Description:

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

Treatment:

Drug: desmopressin

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: desmopressin