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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
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Brief Summary:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 :
  1. Number of allogeneic and autologous blood units transfused (in digits). [ Time Frame: 48-72 hours after surgery. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Dr.Ibrahim Mamdouh Esmat, MD, Lecturer of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals, Ain Shams University
ClinicalTrials.gov Identifier: NCT02747615    
Other Study ID Numbers: 586
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Dr.Ibrahim Mamdouh Esmat, Ain Shams University:
Preoperative autologous blood donation, allogeneic blood transfusion, parenteral iron, tranexamic acid, revision total hip arthroplasty, hemoglobin, hematocrit
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants