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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT01994330 (opens ClinicalTrials.gov in a new tab)Other idRVA
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Overview

Status
Completed
Phase
Phase 4
Enrollment
13 participants (actual)
Sponsor
Pontificia Universidad Catolica de Chile · Other
Design
Randomized · Quadruple masking
Countries
1 country

Chile

Start
Jun 2009
Primary completion
Dec 2009
Completion
Feb 2010
First posted
25 Nov 2013 (estimated)
Last update posted
5 Apr 2017
Conditions
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis · Heye´s Syndrome · Severe Aortic Stenosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 4

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

    NCT01994330

    Jun 2009 to Feb 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • desmopressinDrug

Arms2

  • 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

  • Placebo comparator

    placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. blood loss

    Time frame · once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration

    Registry description

    Blood loss obtained from fluid balance of surgery plus drain output

Secondary outcomes(2)

  1. postoperative hematocrit

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

    Registry description

    hematocrit and hemoglobin in time frame mentioned

  2. need of transfusion

    Time frame · 48 hours post administration

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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