Desmopressin in Cardiac Surgery

Phase 4

Completed

• Conditions: Hemorrhage; Postoperative Hemorrhage; Blood Loss, Surgical
• Interventions: Drug: Placebo; Drug: Desmopressin (DDAVP)

• Registration Number: NCT00337766
• Lead Sponsor: Università Vita-Salute San Raffaele

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

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Primary Completion: 2009-09
• Study Completion: 2010-09
• Status Verified: 2013-05
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• undergoing cardiac surgery
• excessive bleeding

Exclusion Criteria

• age<18 y
• not signing written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Desmopressin (DDAVP)	Desmopressin (DDAVP)	-

Primary Outcome Measures

Name	Time	Method
Reduce transfusions

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, 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