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Desmopressin in Cardiac Surgery

Primary Purpose

Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Desmopressin (DDAVP)
Placebo
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage focused on measuring Blood Loss, Postoperative Blood loss

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: undergoing cardiac surgery excessive bleeding Exclusion Criteria: age<18 y not signing written consent

Sites / Locations

  • Istituto Ospedaliero Fondazione Poliambulanza
  • Istituto Policlinico S.Donato
  • Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
  • Azienda Ospedaliera Universitaria Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Desmopressin (DDAVP)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduce transfusions

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2006
Last Updated
October 20, 2015
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00337766
Brief Title
Desmopressin in Cardiac Surgery
Official Title
Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage
Keywords
Blood Loss, Postoperative Blood loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Desmopressin (DDAVP)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desmopressin (DDAVP)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduce transfusions
Secondary Outcome Measure Information:
Title
Reduced bleeding
Title
Reduce time on mechanical ventilation
Title
Reduced ICU and Hospital stay
Title
Reduced mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing cardiac surgery excessive bleeding Exclusion Criteria: age<18 y not signing written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe Crescenzi, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ospedaliero Fondazione Poliambulanza
City
Brescia
Country
Italy
Facility Name
Istituto Policlinico S.Donato
City
Milano
Country
Italy
Facility Name
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19034103
Citation
Crescenzi G, Landoni G, Biondi-Zoccai G, Pappalardo F, Nuzzi M, Bignami E, Fochi O, Maj G, Calabro 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.
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Desmopressin in Cardiac Surgery

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