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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
History of Changes
  Purpose

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.


Condition Intervention
Kidney Failure
Intraoperative Complications
 Procedure: Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • renal function

Secondary Outcome Measures:
  • other organ damage
  • prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
  • sepsis
  • exitus

Study Start Date: November 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364494

Locations
Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milano, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364494     History of Changes
Other Study ID Numbers: DS/URC/ER/mm 556/DG
Study First Received: August 11, 2006
Last Updated: August 13, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
Hematocrit
Hemodilution
Blood Transfusion
Cardiopulmonary Bypass
 Multiple Organ Failure
Surgery, Cardiac
Kidney Failure
Cardiac Surgical Procedures

Additional relevant MeSH terms:
Intraoperative Complications
Renal Insufficiency
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 13, 2013