Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty

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 knee arthroplasty.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 210
• 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: 20 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 osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and 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 Assignment
• 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
Total blood loss on the post-operative day 1	1 day post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin (Hb)	g/L	7 day
Hematocrit (Hct)	Percentage	7 day
Blood platelet count (PLT)		7 day
Post-operation Hospital for special surgery score (HSS)	Scoring	3 months
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)	There is only one Unit of Measure for ROM, it is degree	Through study completion, an average of 3 months
Length of hospital stay (days)	Days	3 months
Number of patients with infection	Post-operatively	3 months
Number of deep vein thrombosis (DVT) cases	Post-operatively	1 month
Number of pulmonary embolism (PE) cases	Post-operatively	1 month
Intraoperative blood loss	Post-operatively	3 hours
Intravenous fluid administration on the operation day	Milliliter	1 day
Total blood loss on the post-operative day 3	Milliliter	3 day post-operation
Reaction time (R-time)		24 hours
Rate of thrombus formation (K time)		24 hours
Maximum amplitude (MA)		24 hours
Rate of thrombus formation (α-angle)		24 hours
Lysis rate at 30 min (LY30)		24 hours
Coagulation index (CI)		24 hours
Interleukin(IL)-1β		24 hours
Interleukin(IL)-6		24 hours
Interleukin(IL)-8		24 hours
Tumor necrosis factor (TNF)-α		24 hours
C-reactive protein (CRP)		24 hours
Interleukin(IL)-10		24 hours
Wound score		14 day
Blood transfusion rate		7 day
Blood transfusion volume (mL)		7 day

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion: July 1, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Epinephrine; Tranexamic acid; Arthroplasty, Replacement, Knee
• 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: Knee blood

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO