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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthropathy of Knee
• Intervention / Treatment: Drug: Tranexamic acid

• Study Type: Observational
• Enrollment (Anticipated): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients received primary total knee arthroplasty.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tranexamic acid group; 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.	Drug: 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.
Non-tranexamic acid group; During the total knee arthroplasty, the patients did not receive tranexamic acid administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R time	R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.	day0 (pre-operative)
R time	R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.	day3 (post-operative)
K time	K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.	day0 (pre-operative)
K time	K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.	day3 (post-operative)
Alpha angle	Alpha angle is the angle between the baseline and the tangent to the thrombelastography curve through the starting point of coagulation.	day0 (pre-operative)
Alpha angle	Alpha angle is the angle between the baseline and the tangent to the thrombelastography curve through the starting point of coagulation.	day3 (post-operative)
Maximal amplitude (MA)	Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.	day0 (pre-operative)
Maximal amplitude (MA)	Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.	day3 (post-operative)
Clot index (CI)	Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.	day0 (pre-operative)
Clot index (CI)	Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.	day3 (post-operative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prothrombin time (PT)	Prothrombin time (PT) is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Prothrombin time (PT)	Prothrombin time (PT) is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Activated partial thromboplastin time (APTT)	Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Activated partial thromboplastin time (APTT)	Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Hemoglobin in g/L	Hemoglobin is a parameter which reflects the blood loss or anemia.	day0 (pre-operative)
Hemoglobin in g/L	Hemoglobin is a parameter which reflects the blood loss or anemia.	day3 (post-operative)
Red blood cell specific volume (HCT)	Red blood cell specific volume (HCT) is a parameter which reflects the ratio of the red blood cells in the whole blood.	day0 (pre-operative)
Red blood cell specific volume (HCT)	Red blood cell specific volume (HCT) is a parameter which reflects the ratio of the red blood cells in the whole blood.	day3 (post-operative)
Fibrinogen in g/L	Fibrinogen is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Fibrinogen in g/L	Fibrinogen is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Platelet count in 10^9g/L	Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.	day0 (pre-operative)
Platelet count in 10^9g/L	Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.	day3 (post-operative)

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 5, 2022
• Primary Completion (Anticipated): August 20, 2022
• Study Completion (Anticipated): August 28, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Thrombelastography; Coagulation Function
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: IIT-2022-0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No