Desmopressin in Cardiac Surgery

This study is currently recruiting participants.

Verified December 2010 by Università Vita-Salute San Raffaele

First Received on June 15, 2006. Last Updated on December 28, 2010 History of Changes

Sponsor:	Università Vita-Salute San Raffaele
Information provided by:	Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT00337766

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 IV

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:

Genetics Home Reference related topics: neurohypophyseal diabetes insipidus

MedlinePlus related topics: Blood Transfusion and Donation Diabetes Insipidus Heart Surgery

Drug Information available for: Vasopressins Desmopressin Desmopressin acetate Arginine Argipressin Arginine hydrochloride

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:

Crescenzi G, Landoni G, Biondi-Zoccai G, Pappalardo F, Nuzzi M, Bignami E, Fochi O, Maj G, Calabrò MG, Ranucci M, Zangrillo A. Desmopressin reduces transfusion needs after surgery: a meta-analysis of randomized clinical trials. Anesthesiology. 2008 Dec;109(6):1063-76.

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 February 12, 2012