Phase 4
N=60
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
Revision Total Hip Arthroplasty (RTHA)
Bottom Line
View on ClinicalTrials.gov: NCT02747615 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Transfused Allogeneic Blood Units (in Digits). — 2.0; 0.0 units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- transfused pre-operatively donated autologous blood. (Other); intravenous tranexamic acid (TXA) infusion (Drug); transfused only allogeneic blood. (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Ain Shams University
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Transfused Allogeneic Blood Units (in Digits). |
2.0; 0.0 | — |
| SECONDARY Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). |
5.27; 3.20 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02747615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.