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

Southwest Hospital, China200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Blood Loss

Interventions

Tranexamic acid (TXA)DRUG

IV and topical administration

EpinephrineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Southwest Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Blood loss on post-operative day 1

Time frame: 1 day

Secondary Outcomes

Length of hospital stay

Time frame: 1 months

Number of patients with infection

Time frame: 1 months

Number of deep vein thrombosis cases

Time frame: 1 months

Number of pulmonary embolism cases

Time frame: 1 months

Number of plexus venosus leg muscle thrombosis

Time frame: 1 months

Serum levels of IL-10（Preoperation, intraoperation and post-operation）

Time frame: Preoperation, intraoperation and up to 2 days post-operation

Serum levels of IL-6（Preoperation, intraoperation and post-operation）

Time frame: Preoperation, intraoperation and up to 2 days post-operation

Serum levels of IL-1β（Preoperation, intraoperation and post-operation）

Time frame: Preoperation, intraoperation and up to 2 days post-operation

Serum levels of TNF-α（Preoperation, intraoperation and post-operation）

Time frame: Preoperation, intraoperation and up to 2 days post-operation

Haemoglobin (Hb)

Time frame: 7 days

Data from ClinicalTrials.gov

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