NCT01994330

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

November 14, 2013

Last Update Submit

April 4, 2017

Conditions

Acquired Von Willebrand Disease Secondary to Severe Aortic StenosisHeye´s SyndromeSevere Aortic Stenosis

Keywords

acquired von Willebrand diseasesevere aortic stenosisHeye´s syndromedesmopressinvon Willebrand multimers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • postoperative hematocrit

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

  • need of transfusion

    48 hours post administration

Other Outcomes (2)

  • incidence of hyponatremia

    18-24 hours post administration of study drug

  • von Willebrand study and protein electrophoresis

    the day of surgery, half hour previous to administration of study drug

Study Arms (2)

Desmopressin

EXPERIMENTAL

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

Drug: desmopressin

placebo

PLACEBO COMPARATOR

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

Drug: desmopressin

Interventions

desmopressinDRUG

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

Also known as: DDAVP
Desmopressinplacebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • esperanza carrasco, anesthesiologist

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • rodrigo lopez, anesthesiologist

    Pontificia Universidad Catolica de Chile

    STUDY DIRECTOR

  • guillermo lema, profesor titular

    Pontificia Universidad Catolica de Chile

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 25, 2013

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

CL(1)