Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-10-31

Brief Summary

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Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.

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Detailed Description

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A total of 60 patients were included in this randomized study that were divided into a study group of 30 patients, who had been transfused autologous blood and a control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 g of intravenous TXA.

This study was conducted through laboratory analysis of hemoglobin and hematocrit values during blood donation and for both groups in the preoperative and the postoperative period and the assessment of the amount of transfused blood units in both groups.

Conditions

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Revision Total Hip Arthroplasty (RTHA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group (n=30)

The control group, which consisted of 30 patients who were transfused only allogeneic blood.

Group Type OTHER

transfused only allogeneic blood.

Intervention Type OTHER

Preoperative blood donation (n=30)

the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.

Group Type ACTIVE_COMPARATOR

transfused pre-operatively donated autologous blood.

Intervention Type OTHER

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion

intravenous tranexamic acid (TXA) infusion

Intervention Type DRUG

Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.

Interventions

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transfused pre-operatively donated autologous blood.

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion

Intervention Type OTHER

intravenous tranexamic acid (TXA) infusion

Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.

Intervention Type DRUG

transfused only allogeneic blood.

Intervention Type OTHER

Other Intervention Names

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Pre-operative autologous donation Kapron®

Eligibility Criteria

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Inclusion Criteria

* Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.

Exclusion Criteria

* This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No