Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
- Registration Number
- NCT02860221
- Lead Sponsor
- Southwest Hospital, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical epinephrine Tranexamic acid (TXA) Topical epinephrine Topical epinephrine Epinephrine Topical epinephrine Intravenous epinephrine Epinephrine Intravenous (IV) low dose epinephrine Intravenous epinephrine Tranexamic acid (TXA) Intravenous (IV) low dose epinephrine Control Tranexamic acid (TXA) No epinephrine
- Primary Outcome Measures
Name Time Method Total blood loss on the post-operative day 1 1 day post-operation
- Secondary Outcome Measures
Name Time Method Number of deep vein thrombosis (DVT) cases 1 month Post-operatively
Number of pulmonary embolism (PE) cases 1 month Post-operatively
Intraoperative blood loss 3 hours Post-operatively
Hematocrit (Hct) 7 day Percentage
Blood platelet count (PLT) 7 day Haemoglobin (Hb) 7 day g/L
Post-operation Hospital for special surgery score (HSS) 3 months Scoring
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree) Through study completion, an average of 3 months There is only one Unit of Measure for ROM, it is degree
Length of hospital stay (days) 3 months Days
Number of patients with infection 3 months Post-operatively
Total blood loss on the post-operative day 3 3 day post-operation Milliliter
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 Milliliter
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
Trial Locations
- Locations (1)
Southwest Hospital
🇨🇳Chongqing, Chongqing, China