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Completed

NCT Number: NCT01994330

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

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Key information

Conditions

Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heye´s Syndrome Severe Aortic Stenosis Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Desmopressin

Drug

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

Other names: DDAVP

Primary outcomes

  1. blood loss

    Time frame: 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 outcomes

  1. postoperative hematocrit

    Time frame: the morning after surgery (18-24 hours after drug administration)

    hematocrit and hemoglobin in time frame mentioned

  2. need of transfusion

    Time frame: 48 hours post administration

    transfusion of packaged red cells units until 48 hours after administration of study drug

Other outcomes

  1. incidence of hyponatremia

    Time frame: 18-24 hours post administration of study drug

    blood sampling for plasma sodium in specified time frame

  2. von Willebrand study and protein electrophoresis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Nov 25, 2013
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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