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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (n=30) | Other | The control group, which consisted of 30 patients who were transfused only allogeneic blood. |
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| Preoperative blood donation (n=30) | Active Comparator | the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transfused pre-operatively donated autologous blood. | Other | Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Transfused Allogeneic Blood Units (in Digits). | 48-72 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). | 48-72 hours after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group (n=30) | The control group, which consisted of 30 patients who were transfused only allogeneic blood. transfused only allogeneic blood. |
| FG001 | Preoperative Blood Donation (n=30) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| intravenous tranexamic acid (TXA) infusion | Drug | Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery. |
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| transfused only allogeneic blood. | Other |
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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
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group (n=30) | The control group, which consisted of 30 patients who were transfused only allogeneic blood. transfused only allogeneic blood. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Number of Transfused Allogeneic Blood Units (in Digits). | Posted | Median | Inter-Quartile Range | units | 48-72 hours after surgery. |
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| Secondary | Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days). | Posted | Mean | Standard Deviation | days | 48-72 hours after surgery. |
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Adverse event data were collected over 24 hours postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group (n=30) | The control group, which consisted of 30 patients who were transfused only allogeneic blood. transfused only allogeneic blood. | 0 | 30 | 0 | 30 | ||
| EG001 | 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 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ibrahim Mamdouh Esmat | Ain-Shams University Hospitals | 01001241928 | ibrahim_mamdouh@med.asu.edu.eg |
| Between 18 and 65 years |
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| >=65 years |
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