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

Overview

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.

Full Title of Study: “Alteration of Thrombelastography and Hemostatic Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 20, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Non-tranexamic acid group
    • During the total knee arthroplasty, the patients did not receive tranexamic acid administration.

Clinical Trial Outcome Measures

Primary Measures

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

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lin Du, Study Chair, RenJi Hospital
  • Overall Contact(s)
    • Lin Du, 86-13817371926, sato316@163.com

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