Hemodilution and Outcome in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Failure Intraoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No