Revision Total Hip Arthroplasty (RTHA)
Conditions
Keywords
Autologous blood donation, allogeneic blood transfusion
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.
Detailed 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.
Interventions
OTHERtransfused pre-operatively donated autologous blood.
Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion
Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.
OTHERtransfused only allogeneic blood.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Transfused Allogeneic Blood Units (in Digits). | 48-72 hours after surgery. |
Secondary
| Measure | Time frame |
|---|---|
| Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). | 48-72 hours after surgery. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group (n=30) The control group, which consisted of 30 patients who were transfused only allogeneic blood.
transfused only allogeneic blood. | 30 |
| Preoperative Blood Donation (n=30) the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
transfused pre-operatively donated autologous blood.
intravenous tranexamic acid (TXA) infusion | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Preoperative Blood Donation (n=30) | Total | Control Group (n=30) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 60 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 67.4 years STANDARD_DEVIATION 4.1 | 67.6 years STANDARD_DEVIATION 4.2 | 67.8 years STANDARD_DEVIATION 4.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Egypt | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Transfused Allogeneic Blood Units (in Digits).
Time frame: 48-72 hours after surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group (n=30) | Number of Transfused Allogeneic Blood Units (in Digits). | 2.0 units |
| Preoperative Blood Donation (n=30) | Number of Transfused Allogeneic Blood Units (in Digits). | 0.0 units |
Secondary
Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).
Time frame: 48-72 hours after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (n=30) | Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). | 5.27 days | Standard Deviation 1.11 |
| Preoperative Blood Donation (n=30) | Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). | 3.20 days | Standard Deviation 0.41 |