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

A

Ain Shams University

Status and phase

Completed
Phase 4

Conditions

Revision Total Hip Arthroplasty (RTHA)

Treatments

Other: transfused pre-operatively donated autologous blood.
Drug: intravenous tranexamic acid (TXA) infusion
Other: transfused only allogeneic blood.

Study type

Interventional

Funder types

Other

Identifiers

NCT02747615
586

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Control group (n=30)
Other group
Description:
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
Treatment:
Other: transfused only allogeneic blood.
Preoperative blood donation (n=30)
Active Comparator group
Description:
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
Treatment:
Drug: intravenous tranexamic acid (TXA) infusion
Other: transfused pre-operatively donated autologous blood.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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