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Desmopressin in Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Università Vita-Salute San Raffaele.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00337766
First received: June 15, 2006
Last updated: December 28, 2010
Last verified: December 2010
History of Changes
  Purpose

Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products.

Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.


Condition Intervention Phase
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
 Drug: Desmopressin (DDAVP)
Other: Placebo Comparator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Reduce transfusions

Secondary Outcome Measures:
  • Reduced bleeding
  • Reduce time on mechanical ventilation
  • Reduced ICU and Hospital stay
  • Reduced mortality

Study Start Date: June 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desmopressin (DDAVP) Drug: Desmopressin (DDAVP)
Placebo Comparator: Placebo Other: Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing cardiac surgery
  • excessive bleeding

Exclusion Criteria:

  • age<18 y
  • not signing written consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337766

Contacts
Contact: giovanni landoni, MD +39.347.2520801 landoni.giovanni@hsr.it
Contact: crescenzi giuseppe, MD crescenzi.giuseppe@hsr.it

Locations
Italy
Istituto Ospedaliero Fondazione Poliambulanza Not yet recruiting
Brescia, Italy
Principal Investigator: Elena Conti, MD            
Sub-Investigator: Gregorio Finamore            
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia Recruiting
Milan, Italy, 20132
Istituto Policlinico S.Donato Recruiting
Milano, Italy
Principal Investigator: Giuseppe Isgrò, MD            
Sub-Investigator: Marco Ranucci, MD            
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy
Contact: Fabio Guarracino, MD         fabiodoc64@hotmail.com    
Principal Investigator: Fabio Guarracino, MD            
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Director: Giovanni Landoni, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
Principal Investigator: Giuseppe Crescenzi, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00337766     History of Changes
Other Study ID Numbers: DS/URC/ER/mm 151/DG
Study First Received: June 15, 2006
Last Updated: December 28, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
Blood Loss
Postoperative Blood loss

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Postoperative Complications
Intraoperative Complications
Arginine Vasopressin
Deamino Arginine Vasopressin
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013