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The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty.
Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration
Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.
The study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinephrine + Tranexamic Acid Group | Experimental | The experimental group will receive both epinephrine and tranexamic acid |
|
| Tranexamic Acid Group | Active Comparator | The comparator group will receive only tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose epinephrine and tranexamic acid | Drug | low-dose epinephrine and tranexamic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative blood loss | Calculated 24 h blood loss in mL, Hidden blood loss in mL, Hemoglobin levels in g/dL, Hematocrit levels as a percentage, Platelets count in cells/µL. | Daily, till post-operative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic complications | Daily, till post-operative day 5 | |
| Hospitalization duration | Daily, till post-operative day 5 | |
| Drug side effects (epinephrine + tranexamic acid) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Turki Althunayan | Contact | +966 55 994 4782 | althunayan.tu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wazzan Aljuhani, MD, FRCSC, MBA, MMEd | King Abdulaziz Medical City, MNGHA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City, Ministry of National Guard - Health Affairs | Recruiting | Riyadh | Riyadh Region | Saudi Arabia |
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| Tranexamic Acid (TXA) treatment | Drug | Tranexamic Acid |
|
| Daily, till post-operative day 5 |
| Complications | VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke | Daily, till post-operative day 5 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D014148 | Tranexamic Acid |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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