The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery

Army Medical University

Status: Unknown

Conditions: Blood Loss

Treatments: Drug: Tranexamic acid (TXA); Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02864095

Hip blood

Details and patient eligibility

About

The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total hip arthroplasty.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients between the ages of 20 and 75 who were diagnosed with as having osteoarthritis or osteonecrosis of the femoral head
• Scheduled for an elective primary total hip arthroplasty
• Those who were willing and able to return for follow-up over at least a 6-month postoperative period

Exclusion criteria

• Acute coronary syndrome < 6 months
• Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium < 3.0 mmol, alcohol abuse, premenopausal women
• Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors
• Patients with history of thromboembolic disease, bleeding disorder
• Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation ) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
• Allergy to TXA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 3 patient groups

Intravenous epinephrine

Experimental group

Description:

Intravenous (IV) low dose epinephrine

Treatment:

Drug: Epinephrine

Drug: Tranexamic acid (TXA)

Topical epinephrine

Experimental group

Description:

Topical epinephrine

Treatment:

Drug: Epinephrine

Drug: Tranexamic acid (TXA)

Control

Active Comparator group

Description:

No epinephrine

Treatment:

Drug: Tranexamic acid (TXA)