Low-dose epinephrine with tranexamic acid during knee replacement
The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
This will test whether giving low-dose epinephrine together with tranexamic acid to people having knee replacement reduces blood loss, clotting complications, and hospital stay.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | King Abdullah International Medical Research Center Academic / other |
| Locations | 1 site (Riyadh, Riyadh Region) |
| Trial ID | NCT07089251 on ClinicalTrials.gov |
What this trial studies
This randomized, superiority Phase 4 trial assigns patients undergoing knee replacement to receive either intravenous low-dose epinephrine plus tranexamic acid or tranexamic acid alone. Allocation is computer-generated and the primary outcomes are 24-hour perioperative blood loss, thromboembolic complications, and length of hospital stay. The protocol estimates 80 total patients based on assumed blood-loss variance, with treatments given perioperatively. The trial is run at a single center in Riyadh and excludes patients with major cardiac, hepatic, renal, or bleeding disorders, recent thromboembolism, pregnancy, or allergies to the study drugs.
Who should consider this trial
Good fit: Adults scheduled for knee joint arthroplasty with complete medical records and without major heart failure, recent myocardial infarction or stroke, significant liver or kidney disease, coagulopathy, recent thromboembolism, pregnancy, or allergy to epinephrine or tranexamic acid are the intended candidates.
Not a fit: Patients with end-stage renal disease, liver cirrhosis, coagulopathy, recent myocardial infarction or stroke, heart failure, arrhythmias, prior thromboembolism, pregnancy, breastfeeding, or allergy to the study drugs are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could have less perioperative bleeding, fewer clotting complications, and shorter hospital stays after knee replacement.
How similar studies have performed: Tranexamic acid is well established to reduce bleeding in knee arthroplasty, but adding low-dose intravenous epinephrine is less studied and this combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing knee joint arthroplasty. * Saudi and Non-Saudi Patient. * Patients who have Complete medical record. Exclusion Criteria: * End stage renal disease * Liver cirrhosis * Coagulopathy * Pre-operative Hgb \<10 5. * History of cerebrovascular accident or myocardial infarction in past 12 months. * History of Heart failure. * History of arrhythmia. * History of pheochromocytoma, thyrotoxicosis and glaucoma. * Pregnancy or breast feeding * History of Deep venous thrombosis or pulmonary embolism * Allergy to epinephrine or tranexamic acid
Where this trial is running
Riyadh, Riyadh Region
- King Abdulaziz Medical City, Ministry of National Guard - Health Affairs — Riyadh, Riyadh Region, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Wazzan Aljuhani, MD, FRCSC, MBA, MMEd — King Abdulaziz Medical City, MNGHA
- Study coordinator: Dr. Turki Althunayan
- Email: althunayan.tu@hotmail.com
- Phone: +966 55 994 4782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.