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

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 Overview

• Status: Unknown
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Epinephrine; Drug: Tranexamic acid (TXA)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intravenous epinephrine; Intravenous (IV) low dose epinephrine	Drug: Epinephrine; Drug: Tranexamic acid (TXA); IV and topical administration
EXPERIMENTAL: Topical epinephrine	Drug: Epinephrine; Drug: Tranexamic acid (TXA); IV and topical administration
ACTIVE_COMPARATOR: Control; No epinephrine	Drug: Tranexamic acid (TXA); IV and topical administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood loss on post-operative day 1	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		1 months
Number of patients with infection		1 months
Number of deep vein thrombosis cases		1 months
Number of pulmonary embolism cases		1 months
Number of plexus venosus leg muscle thrombosis		1 months
Serum levels of IL-10（Preoperation, intraoperation and post-operation）		Preoperation, intraoperation and up to 2 days post-operation
Serum levels of IL-6（Preoperation, intraoperation and post-operation）		Preoperation, intraoperation and up to 2 days post-operation
Serum levels of IL-1β（Preoperation, intraoperation and post-operation）		Preoperation, intraoperation and up to 2 days post-operation
Serum levels of TNF-α（Preoperation, intraoperation and post-operation）		Preoperation, intraoperation and up to 2 days post-operation
Haemoglobin (Hb)		7 days
Hematocrit (Hct)		7 days
Platelets (PLT)		7 days
Blood loss on post-operative day 3		3 days
Preoperation, intraoperation and post-operation R value (min) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Preoperation, intraoperation and post-operation K value (min) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Number of patients with blood transfusion	Number of transfusion cases, number of units transfused and amount of transfusion	7 days

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (ESTIMATE): August 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Epinephrine; Tranexamic acid; Arthroplasty, Replacement, Hip
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Fibrin Modulating Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Tranexamic Acid; Epinephrine
• Other Study ID Numbers: Hip blood

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED