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
About this trial
This is an interventional prevention trial for Hemorrhage focused on measuring Blood Loss, Postoperative Blood loss
Eligibility Criteria
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
NCT ID
NCT00337766
First Posted
June 15, 2006
Last Updated
October 20, 2015
Sponsor
Università Vita-Salute San Raffaele
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.
Results Reference
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Desmopressin in Cardiac Surgery
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