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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014