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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05490160
• Other study ID #: IIT-2022-0059
• Status: Not yet recruiting
• Start date: August 5, 2022
• Est. completion date: August 28, 2022

Study information

• Verified date: July 2022
• Source: RenJi Hospital
• Contact: Lin Du
• Phone: 86-13817371926
• Email: sato316[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: August 28, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R time	R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.	day0 (pre-operative)
Primary	R time	R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.	day3 (post-operative)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Prothrombin time (PT)	Prothrombin time (PT) is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Secondary	Prothrombin time (PT)	Prothrombin time (PT) is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Secondary	Activated partial thromboplastin time (APTT)	Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Secondary	Activated partial thromboplastin time (APTT)	Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Secondary	Hemoglobin in g/L	Hemoglobin is a parameter which reflects the blood loss or anemia.	day0 (pre-operative)
Secondary	Hemoglobin in g/L	Hemoglobin is a parameter which reflects the blood loss or anemia.	day3 (post-operative)
Secondary	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)
Secondary	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)
Secondary	Fibrinogen in g/L	Fibrinogen is one of the parameters which reflects the coagulation function.	day0 (pre-operative)
Secondary	Fibrinogen in g/L	Fibrinogen is one of the parameters which reflects the coagulation function.	day3 (post-operative)
Secondary	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)
Secondary	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)