Clinical trial NCT02864095: The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Keywords: Arthroplasty, Replacement, Hip
Epinephrine
Tranexamic acid
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
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 hip arthroplasty.


Eligibility criteria: 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

Primary outcomes:
measure: Blood loss on post-operative day 1
timeFrame: 1 day
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 months
measure: Number of patients with infection
timeFrame: 1 months
measure: Number of deep vein thrombosis cases
timeFrame: 1 months
measure: Number of pulmonary embolism cases
timeFrame: 1 months
measure: Number of plexus venosus leg muscle thrombosis
timeFrame: 1 months
measure: Serum levels of IL-10（Preoperation, intraoperation and post-operation）
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Serum levels of IL-6（Preoperation, intraoperation and post-operation）
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Serum levels of IL-1β（Preoperation, intraoperation and post-operation）
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Serum levels of TNF-α（Preoperation, intraoperation and post-operation）
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Haemoglobin (Hb)
timeFrame: 7 days
measure: Hematocrit (Hct)
timeFrame: 7 days
measure: Platelets (PLT)
timeFrame: 7 days
measure: Blood loss on post-operative day 3
timeFrame: 3 days
measure: Preoperation, intraoperation and post-operation R value (min) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Preoperation, intraoperation and post-operation K value (min) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram
timeFrame: Preoperation, intraoperation and up to 2 days post-operation
measure: Number of patients with blood transfusion
timeFrame: 7 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: