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

NCT ID: NCT02864095

Last Updated: 2017-07-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Loss

Keywords

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Arthroplasty, Replacement, Hip Epinephrine Tranexamic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intravenous epinephrine

Intravenous (IV) low dose epinephrine

Group Type EXPERIMENTAL

Tranexamic acid (TXA)

Intervention Type DRUG

IV and topical administration

Epinephrine

Intervention Type DRUG

Topical epinephrine

Topical epinephrine

Group Type EXPERIMENTAL

Tranexamic acid (TXA)

Intervention Type DRUG

IV and topical administration

Epinephrine

Intervention Type DRUG

Control

No epinephrine

Group Type ACTIVE_COMPARATOR

Tranexamic acid (TXA)

Intervention Type DRUG

IV and topical administration

Interventions

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Tranexamic acid (TXA)

IV and topical administration

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Liu Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Weinan Zeng, doctor

Role: primary

Other Identifiers

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Hip blood

Identifier Type: -

Identifier Source: org_study_id