Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty

Blood Loss Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02860221
• Other study ID #: Knee blood
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: July 25, 2017
• Start date: May 2015
• Est. completion date: July 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 knee arthroplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

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	Total blood loss on the post-operative day 1		1 day post-operation
Secondary	Haemoglobin (Hb)	g/L	7 day
Secondary	Hematocrit (Hct)	Percentage	7 day
Secondary	Blood platelet count (PLT)		7 day
Secondary	Post-operation Hospital for special surgery score (HSS)	Scoring	3 months
Secondary	Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)	There is only one Unit of Measure for ROM, it is degree	Through study completion, an average of 3 months
Secondary	Length of hospital stay (days)	Days	3 months
Secondary	Number of patients with infection	Post-operatively	3 months
Secondary	Number of deep vein thrombosis (DVT) cases	Post-operatively	1 month
Secondary	Number of pulmonary embolism (PE) cases	Post-operatively	1 month
Secondary	Intraoperative blood loss	Post-operatively	3 hours
Secondary	Intravenous fluid administration on the operation day	Milliliter	1 day
Secondary	Total blood loss on the post-operative day 3	Milliliter	3 day post-operation
Secondary	Reaction time (R-time)		24 hours
Secondary	Rate of thrombus formation (K time)		24 hours
Secondary	Maximum amplitude (MA)		24 hours
Secondary	Rate of thrombus formation (a-angle)		24 hours
Secondary	Lysis rate at 30 min (LY30)		24 hours
Secondary	Coagulation index (CI)		24 hours
Secondary	Interleukin(IL)-1ß		24 hours
Secondary	Interleukin(IL)-6		24 hours
Secondary	Interleukin(IL)-8		24 hours
Secondary	Tumor necrosis factor (TNF)-a		24 hours
Secondary	C-reactive protein (CRP)		24 hours
Secondary	Interleukin(IL)-10		24 hours
Secondary	Wound score		14 day
Secondary	Blood transfusion rate		7 day
Secondary	Blood transfusion volume (mL)		7 day