Back to results

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

Primary Purpose

Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis

Status

Completed

Phase

Phase 4

Locations

Chile

Study Type

Interventional

Intervention

desmopressin

About this trial

This is an interventional treatment trial for Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis focused on measuring acquired von Willebrand disease, severe aortic stenosis, Heye´s syndrome, desmopressin, von Willebrand multimers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Hospital Clínico Universidad Católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desmopressin

placebo

Arm 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

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

Outcomes

Primary Outcome Measures

blood loss

Blood loss obtained from fluid balance of surgery plus drain output

Secondary Outcome Measures

postoperative hematocrit

hematocrit and hemoglobin in time frame mentioned

need of transfusion

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

Full Information

NCT ID

NCT01994330

First Posted

November 14, 2013

Last Updated

April 4, 2017

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01994330

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desmopressin

Arm Type

Experimental

Arm 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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

desmopressin

Other Intervention Name(s)

DDAVP

Intervention Description

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

Primary Outcome Measure Information:

Title

blood loss

Description

Blood loss obtained from fluid balance of surgery plus drain output

Time Frame

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

Secondary Outcome Measure Information:

Title

postoperative hematocrit

Description

hematocrit and hemoglobin in time frame mentioned

Time Frame

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

Title

need of transfusion

Description

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

Time Frame

48 hours post administration

Other Pre-specified Outcome Measures:

Title

incidence of hyponatremia

Description

blood sampling for plasma sodium in specified time frame

Time Frame

18-24 hours post administration of study drug

Title

von Willebrand study and protein electrophoresis

Description

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

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

esperanza carrasco, anesthesiologist

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

rodrigo lopez, anesthesiologist

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

guillermo lema, profesor titular

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Clínico Universidad Católica de Chile

City

Santiago

State/Province

Region Metropolitana

Country

Chile

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs