Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02747615|
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Ain Shams University
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University
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.
|Condition or disease||Intervention/treatment||Phase|
|Revision Total Hip Arthroplasty (RTHA)||Other: transfused pre-operatively donated autologous blood. Drug: intravenous tranexamic acid (TXA) infusion Other: transfused only allogeneic blood.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty: a Randomized Controlled Trial|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Control group (n=30)
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
Other: transfused only allogeneic blood.
Active Comparator: Preoperative blood donation (n=30)
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.
Drug: intravenous tranexamic acid (TXA) infusion
Primary Outcome Measures :
- Number of allogeneic and autologous blood units transfused (in digits). [ Time Frame: 48-72 hours after surgery. ]
Secondary Outcome Measures :
- Our secondary outcome measure was to assess the drop in hemoglobin (gm/dl) after surgery and the post-operative hospital stay (days). [ Time Frame: 48-72 hours after surgery. ]
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