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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthropathy of Knee

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tranexamic acid group<br>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<br>* 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.<br>|
| Non-tranexamic acid group<br>During the total knee arthroplasty, the patients did not receive tranexamic acid administration. | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Thrombelastography, Coagulation Function