Blood Loss
Conditions
Keywords
Arthroplasty, Replacement, Hip, 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 hip 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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients between the ages of 20 and 75 who were diagnosed with as having osteoarthritis or osteonecrosis of the femoral head * Scheduled for an elective primary total hip arthroplasty * 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 |
|---|---|
| Blood loss on post-operative day 1 | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelets (PLT) | 7 days | — |
| Blood loss on post-operative day 3 | 3 days | — |
| Preoperation, intraoperation and post-operation R value (min) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Preoperation, intraoperation and post-operation K value (min) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Length of hospital stay | 1 months | — |
| Number of patients with infection | 1 months | — |
| Number of deep vein thrombosis cases | 1 months | — |
| Number of pulmonary embolism cases | 1 months | — |
| Number of plexus venosus leg muscle thrombosis | 1 months | — |
| Serum levels of IL-10（Preoperation, intraoperation and post-operation） | Preoperation, intraoperation and up to 2 days post-operation | — |
| Serum levels of IL-6（Preoperation, intraoperation and post-operation） | Preoperation, intraoperation and up to 2 days post-operation | — |
| Serum levels of IL-1β（Preoperation, intraoperation and post-operation） | Preoperation, intraoperation and up to 2 days post-operation | — |
| Serum levels of TNF-α（Preoperation, intraoperation and post-operation） | Preoperation, intraoperation and up to 2 days post-operation | — |
| Haemoglobin (Hb) | 7 days | — |
| Hematocrit (Hct) | 7 days | — |
| Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram | Preoperation, intraoperation and up to 2 days post-operation | — |
| Number of patients with blood transfusion | 7 days | Number of transfusion cases, number of units transfused and amount of transfusion |
Countries
China
Outcome results
None listed