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Clinical Trials/NCT02860221
NCT02860221UnknownNot Applicable

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

Southwest Hospital, China1 site in 1 country210 target enrollmentStarted: May 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
210
Locations
1
Primary Endpoint
Total blood loss on the post-operative day 1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intravenous epinephrine

Experimental

Intravenous (IV) low dose epinephrine

Intervention: Tranexamic acid (TXA) (Drug)

Intravenous epinephrine

Experimental

Intravenous (IV) low dose epinephrine

Intervention: Epinephrine (Drug)

Topical epinephrine

Experimental

Topical epinephrine

Intervention: Tranexamic acid (TXA) (Drug)

Topical epinephrine

Experimental

Topical epinephrine

Intervention: Epinephrine (Drug)

Control

Active Comparator

No epinephrine

Intervention: Tranexamic acid (TXA) (Drug)

Outcomes

Primary Outcomes

Total blood loss on the post-operative day 1

Time Frame: 1 day post-operation

Secondary Outcomes

  • Post-operation Hospital for special surgery score (HSS)(3 months)
  • Hematocrit (Hct)(7 day)
  • Blood platelet count (PLT)(7 day)
  • Haemoglobin (Hb)(7 day)
  • Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)(Through study completion, an average of 3 months)
  • Length of hospital stay (days)(3 months)
  • Number of patients with infection(3 months)
  • Number of deep vein thrombosis (DVT) cases(1 month)
  • Number of pulmonary embolism (PE) cases(1 month)
  • Intraoperative blood loss(3 hours)
  • Total blood loss on the post-operative day 3(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)
  • Intravenous fluid administration on the operation day(1 day)
  • 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)

Investigators

Sponsor
Southwest Hospital, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liu Yang

Professor

Southwest Hospital, China

Study Sites (1)

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