NCT05490160

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

August 5, 2022

Status Verified

July 1, 2022

Enrollment Period

15 days

First QC Date

August 1, 2022

Last Update Submit

August 3, 2022

Conditions

Arthropathy of Knee

Keywords

Total Knee ArthroplastyThrombelastographyCoagulation Function

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (12)

  • Prothrombin time (PT)

    day0 (pre-operative)

  • Prothrombin time (PT)

    day3 (post-operative)

  • Activated partial thromboplastin time (APTT)

    day0 (pre-operative)

  • Activated partial thromboplastin time (APTT)

    day3 (post-operative)

  • Hemoglobin in g/L

    day0 (pre-operative)

  • +7 more secondary outcomes

Study Arms (2)

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.

Drug: Tranexamic acid

Non-tranexamic acid group

During the total knee arthroplasty, the patients did not receive tranexamic acid administration.

Interventions

Tranexamic acidDRUG

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.

Tranexamic acid group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients received primary total knee arthroplasty.

You may qualify if:

  • The patients received primary total knee arthroplasty;
  • Normal pre-operative coagulation function;
  • Complete surgery document, transfusion document and relative blood test.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Lin Du

    RenJi Hospital

    STUDY CHAIR

Central Study Contacts

Lin Du

CONTACT

86-13817371926sato316@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 5, 2022

Study Start

August 5, 2022

Primary Completion

August 20, 2022

Study Completion

August 28, 2022

Last Updated

August 5, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share