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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05490160
Enrollment
54
Registered
2022-08-05
Start date
2022-08-05
Completion date
2022-08-28
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee

Keywords

Total Knee Arthroplasty, Thrombelastography, Coagulation Function

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.

Interventions

DRUGTranexamic 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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
R timeday0 (pre-operative)R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.
K timeday0 (pre-operative)K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.
Alpha angleday0 (pre-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)day0 (pre-operative)Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.
Clot index (CI)day0 (pre-operative)Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.

Secondary

MeasureTime frameDescription
Prothrombin time (PT)day0 (pre-operative)Prothrombin time (PT) is one of the parameters which reflects the coagulation function.
Platelet count in 10^9g/Lday0 (pre-operative)Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.
Activated partial thromboplastin time (APTT)day0 (pre-operative)Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.
Hemoglobin in g/Lday0 (pre-operative)Hemoglobin is a parameter which reflects the blood loss or anemia.
Red blood cell specific volume (HCT)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.
Fibrinogen in g/Lday0 (pre-operative)Fibrinogen is one of the parameters which reflects the coagulation function.

Contacts

Primary ContactLin Du
sato316@163.com86-13817371926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026