The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty

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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-16

Study Completion Date

2015-06-15

Brief Summary

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The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

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Detailed Description

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Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.

In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.

The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.

Conditions

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Transfusion Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

Preoperative blood donations 14 day before total hip replacement procedure Donation of one dose of autologous blood 14 day before total hip replacement procedure

Group Type EXPERIMENTAL

Preoperative autologous blood donation, 14 days before surgery

Intervention Type PROCEDURE

Active comparator

Preoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure

Group Type ACTIVE_COMPARATOR

Preoperative autologous blood donation, 72 hours before surgery

Intervention Type PROCEDURE

Other

Without preoperative blood donation

Group Type OTHER

Without preoperative blood donation

Intervention Type PROCEDURE

Interventions

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Preoperative autologous blood donation, 14 days before surgery

Intervention Type PROCEDURE

Preoperative autologous blood donation, 72 hours before surgery

Intervention Type PROCEDURE

Without preoperative blood donation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subject older than 18 years
* subject has primary coxarthrosis
* subject has indication for total hip replacement

Exclusion Criteria

* subject has secondary coxarthrosis
* subject has need for revision endoprosthesis
* history of autoimmune, malignancy or coagulation disorder
* history of myocardial infarct or cerebrovascular insult in last 6 months
* history of angina pectoris and unregulated hypertension
* history of renal or liver failure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No