Desmopressin in Cardiac Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

June 15, 2006

Last Updated Date

August 13, 2009

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduce transfusions

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00337766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduced bleeding
Reduce time on mechanical ventilation
Reduced ICU and Hospital stay
Reduced mortality

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Desmopressin in Cardiac Surgery

Official Title ^ICMJE

Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage

Intervention ^ICMJE

Drug: Desmopressin (DDAVP)
Other: Placebo Comparator

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

undergoing cardiac surgery
excessive bleeding

Exclusion Criteria:

age<18 y
not signing written consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00337766

Responsible Party

Study ID Numbers ^ICMJE

DS/URC/ER/mm 151/DG

Study Sponsor ^ICMJE

Università Vita-Salute San Raffaele

Collaborators ^ICMJE

Investigators ^ICMJE

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.

Information Provided By

Università Vita-Salute San Raffaele

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP