Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration

• Conditions: Arthropathy of Knee
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT05490160
• Lead Sponsor: RenJi Hospital

Brief Summary

The main aim and scope of this study is making comparison about the thrombelastography and coagulation function in patients before and after the total knee arthroplasty with intra-articular tranexamic acid administration. The results may identify the influence of the intra-articular tranexamic acid administration on the relative coagulability monitoring.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study Start: 2022-08-05
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Primary Completion: 2022-08-20
• Study Completion: 2022-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• The patients received primary total knee arthroplasty;
• Normal pre-operative coagulation function;
• Complete surgery document, transfusion document and relative blood test.

Exclusion Criteria

• The patients received complicated total knee arthroplasty;
• Abnormal pre-operative coagulation function caused by some diseases such as hepatic inadequacy, thrombocytopenia et al.
• Incomplete documents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tranexamic acid group	Tranexamic acid	During the total knee arthroplasty, the patients received a 2-g retrograde injection of tranexamic acid through the drain after closure, with subsequent clamping of the drain for 6 hours.

Primary Outcome Measures

Name	Time	Method
R time	day3 (post-operative)	R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.
Maximal amplitude (MA)	day3 (post-operative)	Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.
K time	day3 (post-operative)	K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.
Alpha angle	day3 (post-operative)	Alpha angle is the angle between the baseline and the tangent to the thrombelastography curve through the starting point of coagulation.
Clot index (CI)	day3 (post-operative)	Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.

Secondary Outcome Measures

Name	Time	Method
Activated partial thromboplastin time (APTT)	day3 (post-operative)	Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.
Red blood cell specific volume (HCT)	day3 (post-operative)	Red blood cell specific volume (HCT) is a parameter which reflects the ratio of the red blood cells in the whole blood.
Fibrinogen in g/L	day3 (post-operative)	Fibrinogen is one of the parameters which reflects the coagulation function.
Prothrombin time (PT)	day3 (post-operative)	Prothrombin time (PT) is one of the parameters which reflects the coagulation function.
Platelet count in 10^9g/L	day3 (post-operative)	Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.
Hemoglobin in g/L	day3 (post-operative)	Hemoglobin is a parameter which reflects the blood loss or anemia.