Blood Loss
Conditions
Keywords
Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid
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.
Interventions
DRUGTranexamic acid (TXA)
IV and topical administration
DRUGEpinephrine
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total blood loss on the post-operative day 1 | 1 day post-operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematocrit (Hct) | 7 day | Percentage |
| Blood platelet count (PLT) | 7 day | — |
| 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 |
| 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 |
| Intravenous fluid administration on the operation day | 1 day | Milliliter |
| 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 | — |
| Haemoglobin (Hb) | 7 day | g/L |
| 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 | — |
| Maximum amplitude (MA) | 24 hours | — |
Countries
China
Outcome results
None listed