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

Study Overview
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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.

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.

Official Title
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Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty: a Randomized Controlled Trial

Conditions
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Revision Total Hip Arthroplasty (RTHA)

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group (n=30)<br>The control group, which consisted of 30 patients who were transfused only allogeneic blood. | Other: transfused only allogeneic blood.<br> <br> |
| Active Comparator: Preoperative blood donation (n=30)<br>the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it. | Other: transfused pre-operatively donated autologous blood.<br>* Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion<br>* Other names: Pre-operative autologous donation;Drug: intravenous tranexamic acid (TXA) infusion<br>* Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.<br>* Other names: Kapron®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Transfused Allogeneic Blood Units (in Digits). |  | 48-72 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). |  | 48-72 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous blood donation, allogeneic blood transfusion