Desmopressin in Cardiac Surgery

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337766
• Other study ID #: DS/URC/ER/mm 151/DG
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2006
• Last updated: October 20, 2015
• Start date: June 2006
• Est. completion date: September 2010

Study information

• Verified date: May 2013
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• undergoing cardiac surgery

• excessive bleeding

Exclusion Criteria:

• age<18 y

• not signing written consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Desmopressin (DDAVP)

• Placebo

Locations

Country	Name	City	State
Italy	Istituto Ospedaliero Fondazione Poliambulanza	Brescia
Italy	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Milan
Italy	Istituto Policlinico S.Donato	Milano
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. doi: 10.1097/ALN.0b013e31818db18b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce transfusions
Secondary	Reduced bleeding
Secondary	Reduce time on mechanical ventilation
Secondary	Reduced ICU and Hospital stay
Secondary	Reduced mortality