Clinical trial NCT02860221: Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Keywords: Arthroplasty, Replacement, Knee
Epinephrine
Tranexamic acid
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total blood loss on the post-operative day 1
timeFrame: 1 day post-operation
Secondary outcomes:
measure: Haemoglobin (Hb)
timeFrame: 7 day
measure: Hematocrit (Hct)
timeFrame: 7 day
measure: Blood platelet count (PLT)
timeFrame: 7 day
measure: Post-operation Hospital for special surgery score (HSS)
timeFrame: 3 months
measure: Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)
timeFrame: Through study completion, an average of 3 months
measure: Length of hospital stay (days)
timeFrame: 3 months
measure: Number of patients with infection
timeFrame: 3 months
measure: Number of deep vein thrombosis (DVT) cases
timeFrame: 1 month
measure: Number of pulmonary embolism (PE) cases
timeFrame: 1 month
measure: Intraoperative blood loss
timeFrame: 3 hours
measure: Intravenous fluid administration on the operation day
timeFrame: 1 day
measure: Total blood loss on the post-operative day 3
timeFrame: 3 day post-operation
measure: Reaction time (R-time)
timeFrame: 24 hours
measure: Rate of thrombus formation (K time)
timeFrame: 24 hours
measure: Maximum amplitude (MA)
timeFrame: 24 hours
measure: Rate of thrombus formation (α-angle)
timeFrame: 24 hours
measure: Lysis rate at 30 min (LY30)
timeFrame: 24 hours
measure: Coagulation index (CI)
timeFrame: 24 hours
measure: Interleukin(IL)-1β
timeFrame: 24 hours
measure: Interleukin(IL)-6
timeFrame: 24 hours
measure: Interleukin(IL)-8
timeFrame: 24 hours
measure: Tumor necrosis factor (TNF)-α
timeFrame: 24 hours
measure: C-reactive protein (CRP)
timeFrame: 24 hours
measure: Interleukin(IL)-10
timeFrame: 24 hours
measure: Wound score
timeFrame: 14 day
measure: Blood transfusion rate
timeFrame: 7 day
measure: Blood transfusion volume (mL)
timeFrame: 7 day
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: