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Trial record 3 of 323 for:    "supravalvular aortic stenosis" OR "Stenosis, Aortic" OR "Aortic Valve Stenosis"

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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
MPoblete, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01994330
First received: November 14, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
Heye´s Syndrome
Severe Aortic Stenosis
Drug: desmopressin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • blood loss [ Time Frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration ] [ Designated as safety issue: No ]
    Blood loss obtained from fluid balance of surgery plus drain output


Secondary Outcome Measures:
  • postoperative hematocrit [ Time Frame: the morning after surgery (18-24 hours after drug administration) ] [ Designated as safety issue: No ]
    hematocrit and hemoglobin in time frame mentioned

  • need of transfusion [ Time Frame: 48 hours post administration ] [ Designated as safety issue: No ]
    transfusion of packaged red cells units until 48 hours after administration of study drug


Other Outcome Measures:
  • incidence of hyponatremia [ Time Frame: 18-24 hours post administration of study drug ] [ Designated as safety issue: Yes ]
    blood sampling for plasma sodium in specified time frame

  • von Willebrand study and protein electrophoresis [ Time Frame: the day of surgery, half hour previos to administration of study drug ] [ Designated as safety issue: No ]

    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


Enrollment: 13
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: desmopressin
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Other Name: DDAVP
Placebo Comparator: placebo
100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994330

Locations
Chile
Hospital Clínico Universidad Católica de Chile
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Ferring Pharmaceuticals
Investigators
Principal Investigator: esperanza carrasco, anesthesiologist Pontificia Universidad Catolica de Chile
Study Director: rodrigo lopez, anesthesiologist Pontificia Universidad Catolica de Chile
Study Chair: guillermo lema, profesor titular Pontificia Universidad Catolica de Chile
  More Information

No publications provided

Responsible Party: MPoblete, Anesthesiologist, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01994330     History of Changes
Other Study ID Numbers: RVA
Study First Received: November 14, 2013
Last Updated: November 19, 2013
Health Authority: Chile: Comité de Ética Científico

Keywords provided by Pontificia Universidad Catolica de Chile:
acquired von Willebrand disease
severe aortic stenosis
Heye´s syndrome
desmopressin
von Willebrand multimers

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Syndrome
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Cardiovascular Diseases
Coagulation Protein Disorders
Disease
Genetic Diseases, Inborn
Heart Diseases
Heart Valve Diseases
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014