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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:
ClinicalTrials.gov Identifier:
NCT00364494
First Posted: August 15, 2006
Last Update Posted: August 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università Vita-Salute San Raffaele
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00364494     History of Changes
Other Study ID Numbers: DS/URC/ER/mm 556/DG
First Submitted: August 11, 2006
First Posted: August 15, 2006
Last Update Posted: August 14, 2009
Last Verified: August 2009

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:
Renal Insufficiency
Intraoperative Complications
Kidney Diseases
Urologic Diseases
Pathologic Processes