The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
NCT ID: NCT07089251
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2025-07-15
2027-06-24
Brief Summary
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Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Epinephrine + Tranexamic Acid Group
The experimental group will receive both epinephrine and tranexamic acid
low-dose epinephrine and tranexamic acid
low-dose epinephrine and tranexamic acid
Tranexamic Acid Group
The comparator group will receive only tranexamic acid
Tranexamic Acid (TXA) treatment
Tranexamic Acid
Interventions
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low-dose epinephrine and tranexamic acid
low-dose epinephrine and tranexamic acid
Tranexamic Acid (TXA) treatment
Tranexamic Acid
Eligibility Criteria
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Inclusion Criteria
* Saudi and Non-Saudi Patient.
* Patients who have Complete medical record.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
Responsible Party
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Wazzan Saleh ALJuhani
Principal investigator, Orthopedic Surgeon
Principal Investigators
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Wazzan Aljuhani, MD, FRCSC, MBA, MMEd
Role: PRINCIPAL_INVESTIGATOR
King Abdulaziz Medical City, MNGHA
Locations
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King Abdulaziz Medical City, Ministry of National Guard - Health Affairs
Riyadh, Riyadh Region, Saudi Arabia
Countries
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Central Contacts
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Other Identifiers
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ICTR24/002/9
Identifier Type: -
Identifier Source: org_study_id
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