The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery

Not Applicable

• Conditions: Blood Loss
• Interventions: Drug: Tranexamic acid (TXA); Drug: Epinephrine

• Registration Number: NCT02864095
• 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 hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-31
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Tranexamic acid (TXA)	No epinephrine
Intravenous epinephrine	Tranexamic acid (TXA)	Intravenous (IV) low dose epinephrine
Topical epinephrine	Tranexamic acid (TXA)	Topical epinephrine
Topical epinephrine	Epinephrine	Topical epinephrine
Intravenous epinephrine	Epinephrine	Intravenous (IV) low dose epinephrine

Primary Outcome Measures

Name	Time	Method
Blood loss on post-operative day 1	1 day

Secondary Outcome Measures

Name	Time	Method
Serum levels of IL-10（Preoperation, intraoperation and post-operation）	Preoperation, intraoperation and up to 2 days post-operation
Number of plexus venosus leg muscle thrombosis	1 months
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
Blood loss on post-operative day 3	3 days
Number of pulmonary embolism cases	1 months
Serum levels of IL-6（Preoperation, intraoperation and post-operation）	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
Haemoglobin (Hb)	7 days
Hematocrit (Hct)	7 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 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
Platelets (PLT)	7 days
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

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China