Blood Loss, Epinephrine, Knee Arthritis, Osteoarthritis, Knee Arthroplasty, Total, Total Knee Anthroplasty, Tranexamic Acid Use
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGlow-dose epinephrine and tranexamic acid
low-dose epinephrine and tranexamic acid
Tranexamic Acid
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative blood loss | Daily, till post-operative day 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thromboembolic complications | Daily, till post-operative day 5 | — |
| Hospitalization duration | Daily, till post-operative day 5 | — |
| Drug side effects (epinephrine + tranexamic acid) | Daily, till post-operative day 5 | — |
| Complications | Daily, till post-operative day 5 | VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke |
Countries
Saudi Arabia
Contacts
Primary ContactDr. Turki Althunayan
Outcome results
None listed