Clinical trial NCT05490160: Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
Official title: Alteration of Thrombelastography and Hemostatic Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthropathy of Knee
Keywords: Total Knee Arthroplasty
Thrombelastography
Coagulation Function
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients received primary total knee arthroplasty.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: R time
timeFrame: day0 (pre-operative)
measure: R time
timeFrame: day3 (post-operative)
measure: K time
timeFrame: day0 (pre-operative)
measure: K time
timeFrame: day3 (post-operative)
measure: Alpha angle
timeFrame: day0 (pre-operative)
measure: Alpha angle
timeFrame: day3 (post-operative)
measure: Maximal amplitude (MA)
timeFrame: day0 (pre-operative)
measure: Maximal amplitude (MA)
timeFrame: day3 (post-operative)
measure: Clot index (CI)
timeFrame: day0 (pre-operative)
measure: Clot index (CI)
timeFrame: day3 (post-operative)
Secondary outcomes:
measure: Prothrombin time (PT)
timeFrame: day0 (pre-operative)
measure: Prothrombin time (PT)
timeFrame: day3 (post-operative)
measure: Activated partial thromboplastin time (APTT)
timeFrame: day0 (pre-operative)
measure: Activated partial thromboplastin time (APTT)
timeFrame: day3 (post-operative)
measure: Hemoglobin in g/L
timeFrame: day0 (pre-operative)
measure: Hemoglobin in g/L
timeFrame: day3 (post-operative)
measure: Red blood cell specific volume (HCT)
timeFrame: day0 (pre-operative)
measure: Red blood cell specific volume (HCT)
timeFrame: day3 (post-operative)
measure: Fibrinogen in g/L
timeFrame: day0 (pre-operative)
measure: Fibrinogen in g/L
timeFrame: day3 (post-operative)
measure: Platelet count in 10^9g/L
timeFrame: day0 (pre-operative)
measure: Platelet count in 10^9g/L
timeFrame: day3 (post-operative)
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Lin Du
role: STUDY_CHAIR
References: