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Hemodilution and Outcome in Cardiac Surgery

This study has been terminated.
(difficult enrollment after the primary investigator left the centre)
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00364494
First received: August 11, 2006
Last updated: August 13, 2009
Last verified: August 2009

August 11, 2006
August 13, 2009
November 2006
April 2007   (final data collection date for primary outcome measure)
renal function
Same as current
Complete list of historical versions of study NCT00364494 on ClinicalTrials.gov Archive Site
  • other organ damage
  • prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
  • sepsis
  • exitus
  • other organ damage
  • prolonged mechanical ventilation, ICU and Hospital stay
  • sepsis
  • exitus
Not Provided
Not Provided
 
Hemodilution and Outcome in Cardiac Surgery
Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery.

The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Kidney Failure
  • Intraoperative Complications
Procedure: Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Undergoing cardiac surgery

Exclusion Criteria:

  • Age < 18 years old
  • Not signing written consent
  • Age < 65 years old (subgroup 1)
  • Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00364494
DS/URC/ER/mm 556/DG
Yes
Not Provided
Università Vita-Salute San Raffaele
Not Provided
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
Università Vita-Salute San Raffaele
August 2009

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