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

Blood Loss Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02864095
• Other study ID #: Hip blood
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: July 26, 2017
• Start date: May 2015
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss

Intervention

Drug:
• Tranexamic acid (TXA)
IV and topical administration
• Epinephrine

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss on post-operative day 1		1 day
Secondary	Length of hospital stay		1 months
Secondary	Number of patients with infection		1 months
Secondary	Number of deep vein thrombosis cases		1 months
Secondary	Number of pulmonary embolism cases		1 months
Secondary	Number of plexus venosus leg muscle thrombosis		1 months
Secondary	Serum levels of IL-10(Preoperation, intraoperation and post-operation)		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Serum levels of IL-6(Preoperation, intraoperation and post-operation)		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Serum levels of IL-1ß(Preoperation, intraoperation and post-operation)		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Serum levels of TNF-a(Preoperation, intraoperation and post-operation)		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Haemoglobin (Hb)		7 days
Secondary	Hematocrit (Hct)		7 days
Secondary	Platelets (PLT)		7 days
Secondary	Blood loss on post-operative day 3		3 days
Secondary	Preoperation, intraoperation and post-operation R value (min) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Preoperation, intraoperation and post-operation K value (min) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram		Preoperation, intraoperation and up to 2 days post-operation
Secondary	Number of patients with blood transfusion	Number of transfusion cases, number of units transfused and amount of transfusion	7 days