Clinical trial NCT01994330: Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Official title: Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
Heye´s Syndrome
Severe Aortic Stenosis
Keywords: acquired von Willebrand disease
severe aortic stenosis
Heye´s syndrome
desmopressin
von Willebrand multimers
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2013-11-25
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: blood loss
timeFrame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration
Secondary outcomes:
measure: postoperative hematocrit
timeFrame: the morning after surgery (18-24 hours after drug administration)
measure: need of transfusion
timeFrame: 48 hours post administration
Other outcomes:
measure: incidence of hyponatremia
timeFrame: 18-24 hours post administration of study drug
measure: von Willebrand study and protein electrophoresis
timeFrame: the day of surgery, half hour previous to administration of study drug
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad Católica de Chile
state: Region Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: esperanza carrasco, anesthesiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica de Chile
name: rodrigo lopez, anesthesiologist
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Catolica de Chile
name: guillermo lema, profesor titular
role: STUDY_CHAIR
References: