Desmopressin in Cardiac Surgery

This study is currently recruiting participants.

Verified by Università Vita-Salute San Raffaele, August 2009

First Received: June 15, 2006 Last Updated: August 13, 2009 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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery Surgery

Drug Information available for: Desmopressin Desmopressin acetate Arginine

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:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Desmopressin (DDAVP): Active Comparator	Drug: Desmopressin (DDAVP)
Placebo: Placebo Comparator	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
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
Istituto Ospedaliero Fondazione Poliambulanza	Not yet recruiting
Brescia, Italy
Principal Investigator: Elena Conti, MD
Sub-Investigator: Gregorio Finamore
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.

Study ID Numbers:	DS/URC/ER/mm 151/DG
Study First Received:	June 15, 2006
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00337766 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:

Blood Loss
Postoperative Blood loss

Additional relevant MeSH terms:

Coagulants
Hematologic Agents
Physiological Effects of Drugs
Postoperative Hemorrhage
Blood Loss, Surgical
Cardiovascular Agents
Hemorrhage
Intraoperative Complications

Pharmacologic Actions
Hemostatics
Pathologic Processes
Postoperative Complications
Natriuretic Agents
Therapeutic Uses
Deamino Arginine Vasopressin
Antidiuretic Agents

ClinicalTrials.gov processed this record on November 25, 2009