Arthropathy of KneeNCT05490160
Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
An observational study of Arthropathy of Knee, run by RenJi Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2022to 28 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients received primary total knee arthroplasty.
Who may be able to join
- The patients received primary total knee arthroplasty;
- Normal pre-operative coagulation function;
- Complete surgery document, transfusion document and relative blood test.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Alteration of Thrombelastography and Hemostatic Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
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.
- Conditions
- Arthropathy of Knee
- Being tested
- Tranexamic acid
- Keywords
- Total Knee Arthroplasty, Thrombelastography, Coagulation Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tranexamic acid | |
| Non-tranexamic acid group | During the total knee arthroplasty, the patients did not receive tranexamic acid administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R time
R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.
Measured: day0 (pre-operative)
R time
R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day3 (post-operative)
Secondary outcomes (12)
Prothrombin time (PT)
Prothrombin time (PT) is one of the parameters which reflects the coagulation function.
Measured: day0 (pre-operative)
Prothrombin time (PT)
Prothrombin time (PT) is one of the parameters which reflects the coagulation function.
Measured: day3 (post-operative)
Activated partial thromboplastin time (APTT)
Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.
Measured: day0 (pre-operative)
Activated partial thromboplastin time (APTT)
Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.
Measured: day3 (post-operative)
Hemoglobin in g/L
Hemoglobin is a parameter which reflects the blood loss or anemia.
Measured: day0 (pre-operative)
Hemoglobin in g/L
Hemoglobin is a parameter which reflects the blood loss or anemia.
Measured: day3 (post-operative)
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.
Measured: day0 (pre-operative)
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.
Measured: day3 (post-operative)
Fibrinogen in g/L
Fibrinogen is one of the parameters which reflects the coagulation function.
Measured: day0 (pre-operative)
Fibrinogen in g/L
Fibrinogen is one of the parameters which reflects the coagulation function.
Measured: day3 (post-operative)
Platelet count in 10^9g/L
Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.
Measured: day0 (pre-operative)
Platelet count in 10^9g/L
Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.
Measured: day3 (post-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start5 Aug 2022 (estimated)
- Primary completion20 Aug 2022 (estimated)
- Study completion28 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490160
- Sponsor's protocol ID
- IIT-2022-0059
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Thrombelastography and Hemostatic Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
- ClinicalTrials.gov ID
- NCT05490160
- Acronym / sponsor ID
- IIT-2022-0059
- Conditions
- Arthropathy of Knee
- Keywords
- Total Knee Arthroplasty, Thrombelastography, Coagulation Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 5 Aug 2022 (estimated)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 28 Aug 2022 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | – | Drug: Tranexamic acidDuring 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients received primary total knee arthroplasty.
Key inclusion criteria (3 listed)
- The patients received primary total knee arthroplasty;
- Normal pre-operative coagulation function;
- Complete surgery document, transfusion document and relative blood test.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidDuring 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 group |
Primary outcome
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.
12 secondary outcomes
Prothrombin time (PT)
Time frame: day0 (pre-operative)
Prothrombin time (PT)
Time frame: day3 (post-operative)
Activated partial thromboplastin time (APTT)
Time frame: day0 (pre-operative)
Activated partial thromboplastin time (APTT)
Time frame: day3 (post-operative)
Hemoglobin in g/L
Time frame: day0 (pre-operative)
Hemoglobin in g/L
Time frame: day3 (post-operative)
Red blood cell specific volume (HCT)
Time frame: day0 (pre-operative)
Red blood cell specific volume (HCT)
Time frame: day3 (post-operative)
Fibrinogen in g/L
Time frame: day0 (pre-operative)
Fibrinogen in g/L
Time frame: day3 (post-operative)
Platelet count in 10^9g/L
Time frame: day0 (pre-operative)
Platelet count in 10^9g/L
Time frame: day3 (post-operative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Du study chair
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Knee, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Du (86-13817371926, sato316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R time (time frame: day0 (pre-operative)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.