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Hemodilution and Outcome in Cardiac Surgery

NCT00364494 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2009-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Giovanni Landoni, MD · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

  • Giuseppe Crescenzi, MD · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364494 on ClinicalTrials.gov