The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low-dose epinephrine and tranexamic acid, Tranexamic Acid (TXA) treatment.
- Who it may be relevant to
- Registry conditions: Knee Arthroplasty, Total, Knee Arthritis, Osteoarthritis, Total Knee Anthroplasty, Blood Loss. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug low-dose epinephrine and tranexamic acid
low-dose epinephrine and tranexamic acid - Drug Tranexamic Acid (TXA) treatment
Tranexamic Acid
Primary outcome measures
- Perioperative blood loss [Time frame: Daily, till post-operative day 5]
Secondary outcome measures (4)
- Thromboembolic complications [Time frame: Daily, till post-operative day 5]
- Hospitalization duration [Time frame: Daily, till post-operative day 5]
- Drug side effects (epinephrine + tranexamic acid) [Time frame: Daily, till post-operative day 5]
- Complications [Time frame: Daily, till post-operative day 5]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- King Abdulaziz Medical City, Ministry of National Guard - Health Affairs — Riyadh
Identifiers
NCT: NCT07089251 · ICTR24/002/9