Osteoarthritis, KneeTNAKneeNCT07174895
Tranexamic Acid and Drain Use in Knee Arthroplasty
A study testing Intra-articular Tranexamic Acid + Suction Drainage, Intra-articular Tranexamic Acid and Suction Drainage Only in people with Osteoarthritis, Knee, run by Idlib University at 1 site in Syria.
Trial summary
This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intra-articular Tranexamic Acid + Suction Drainage, Intra-articular Tranexamic Acid and Suction Drainage Only
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSyria
- Study dates
- 6 Aug 2021to 1 Apr 2025
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with degenerative knee arthritis
- Scheduled for unilateral total knee arthroplasty
Who cannot join
- Rheumatoid arthritis
- Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events)
- Coagulation disorders or thromboembolic disorders
- Severe infections
- Other serious health issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tranexamic Acid With/Without Drain in Knee Arthroplasty: A Study From Northwest Syria
This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. A total of 192 patients will be randomly assigned to three groups: Group 1 will receive TNA with suction drainage, Group 2 will receive TNA only, and Group 3 will receive suction drainage only.
The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.
Read the detailed description
Total knee arthroplasty (TKA) is commonly associated with significant perioperative blood loss, which may increase transfusion requirements and associated risks such as immunologic reactions, infection, and delayed recovery. Tranexamic acid (TNA) is an antifibrinolytic agent that inhibits fibrinolysis by blocking the activation of plasminogen. Suction drainage is frequently used to prevent hematoma formation, but its benefit in reducing transfusion needs remains controversial.
This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively.
The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intra-articular Tranexamic Acid + Suction Drainage, Intra-articular Tranexamic Acid, Suction Drainage Only
- Keywords
- Arthroplasty, Replacement, Knee Tranexamic Acid Blood Loss, Surgical Drainage Perioperative Care Hemostasis, Surgical Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular Tranexamic Acid + Suction DrainageDrug
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively.
Intra-articular Tranexamic AcidDrug
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.
Suction Drainage OnlyDevice
Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid with Suction Drainage | Experimental | Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. A closed suction drain was inserted intra-articularly and subcutaneously, activated two hours postoperatively. Receives: Drug: Intra-articular Tranexamic Acid + Suction Drainage |
| Tranexamic Acid without Drainage | Experimental | Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. No suction drain was used in this group. Receives: Drug: Intra-articular Tranexamic Acid |
| Suction Drainage without Tranexamic Acid | Active comparator | Patients undergoing total knee arthroplasty had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered in this group. Receives: Device: Suction Drainage Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula.
Measured: Within 72 hours after surgery
Secondary outcomes (7)
Hidden Blood Loss
Hidden blood loss calculated as total blood loss minus drainage volume.
Measured: Within 72 hours after surgery
Drainage Volume
Total drainage collected through suction drains when applicable.
Measured: 24 hours postoperatively
Number of Blood Transfusions
Number of patients receiving blood transfusions based on NIH Consensus criteria (Hb < 8.0 g/dL, or <10.0 g/dL with symptoms).
Measured: During hospital stay (up to 7 days postoperatively)
Postoperative Limb Swelling
Change in limb circumference at thigh, knee, and calf compared with preoperative baseline.
Measured: 1, 2, 4, and 6 weeks postoperatively
Wound-related Complications
Incidence of wound-related issues, including infection, hematoma, erythema, or superficial wound complications.
Measured: Within 6 weeks after surgery
Thromboembolic Events (DVT/PE)
Incidence of deep vein thrombosis (DVT) confirmed with Doppler ultrasonography and pulmonary embolism (PE) if suspected clinically.
Measured: Within 6 weeks after surgery
Postoperative Knee Range of Motion
Range of motion measured with a goniometer (flexion and extension).
Measured: 2 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start6 Aug 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \> This is a prospective randomized clinical trial including 192 patients undergoing total knee arthroplasty. Participants were randomly assigned to one of three groups to assess the effects of intra-articular tranexamic acid and/or suction drainage on total and hidden blood loss, transfusion requirements, postoperative limb swelling, wound-related complications, and knee range of motion.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idlib University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhmoud Adnan Al salamah, Idlib University
- Investigators
- Mhmoud Adnan Al-Salamah, Principal investigator, Idlib University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174895
- Sponsor's protocol ID
- T.A in Knee Arthroplasty
- Other IDs
- NW-Syria-TKA-Study-01
- Acronym
- TNAKnee
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou C, Gao X, Han H, Wang L, Jiang H. The efficacy and safety of tranexamic acid in primary total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024;19(1):37. doi:10.1177/15563316231208716.
Gonzalez-Pola R, Tafoya-Olivos RO, Culebras-Almeida LA, Zermeno-Garcia G, Herrera-Lozano A. Minimizing bleeding and transfusion in single-stage bilateral hip and knee arthroplasty: A systematic review of current interventions. Rev Esp Cir Ortop Traumatol. 2025 Sep-Oct;69(5):532-543. doi: 10.1016/j.recot.2025.04.017. Epub 2025 May 7. English, Spanish.
PubMed 42023914Hishimura R, Onodera T, Ohkoshi Y, Okada K, Matsuoka M, Matsubara S, Iwasaki K, Kondo E, Iwasaki N. The effect of local injection of tranexamic acid into peri-articular tissue versus drain clamping in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 2;23(1):111. doi: 10.1186/s12891-022-05058-6.
PubMed 35109837Kim MK, Ko SH, Nam YC, Jeon YS, Kwon DG, Ryu DJ. Optimal Release Timing of Drain Clamping to Reduce Postoperative Bleeding after Total Knee Arthroplasty with Intraarticular Injection of Tranexamic Acid. Medicina (Kaunas). 2022 Sep 5;58(9):1226. doi: 10.3390/medicina58091226.
PubMed 36143903Liu CH, Chang CH, Chang YH, Shih HN, Hu CC. Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty-A Prospective Randomized Controlled Trial. Medicina (Kaunas). 2023 Nov 26;59(12):2078. doi: 10.3390/medicina59122078.
PubMed 38138181Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of hypotensive anesthesia and regional anesthesia on intraoperative blood loss in total knee arthroplasty. World J Emerg Surg. 2024;19(1):33. doi:10.1186/s13017-024-00554-7
Chaiyakit P, Kabkaew P, Hongku N, Wattanapreechanon P. Comparison of total blood loss between limited tourniquet use and conventional tourniquet use in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Nov 15;25(1):918. doi: 10.1186/s12891-024-08058-w.
PubMed 39548417Liu Y, Ai J, Teng X, Huang Z, Wu H, Zhang Z, Wang W, Liu C, Zhang H. Risk factor analysis and establishment of a nomogram model to predict blood loss during total knee arthroplasty. BMC Musculoskelet Disord. 2024 Jun 10;25(1):459. doi: 10.1186/s12891-024-07570-3.
PubMed 38858713Shih CH, Hsu CL, Lin YC, Lee MS, Huang TL, Chang JK. The role of tranexamic acid and cryotherapy on acute postoperative pain and blood loss in total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025;20(1):141. doi:10.1186/s13018-025-03744-6.
Liangliang L, Wei H, Tao Z, Pin P, Lianying H. Efficacy and safety of tranexamic acid in reducing hidden blood loss during unilateral total knee arthroplasty: a retrospective study. Front Med (Lausanne). 2025 Jun 3;12:1552893. doi: 10.3389/fmed.2025.1552893. eCollection 2025.
PubMed 40529153
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid With/Without Drain in Knee Arthroplasty: A Study From Northwest Syria
- ClinicalTrials.gov ID
- NCT07174895
- Acronym / sponsor ID
- TNAKnee / T.A in Knee Arthroplasty
- Conditions
- Osteoarthritis, Knee
- Keywords
- Arthroplasty, Replacement, Knee Tranexamic Acid Blood Loss, Surgical Drainage Perioperative Care Hemostasis, Surgical Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Idlib UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 16 Sep 2025 (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.
This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. A total of 192 patients will be randomly assigned to three groups: Group 1 will receive TNA with suction drainage, Group 2 will receive TNA only, and Group 3 will receive suction drainage only.
The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.
Detailed description
Total knee arthroplasty (TKA) is commonly associated with significant perioperative blood loss, which may increase transfusion requirements and associated risks such as immunologic reactions, infection, and delayed recovery. Tranexamic acid (TNA) is an antifibrinolytic agent that inhibits fibrinolysis by blocking the activation of plasminogen. Suction drainage is frequently used to prevent hematoma formation, but its benefit in reducing transfusion needs remains controversial.
This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively.
The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- > This is a prospective randomized clinical trial including 192 patients undergoing total knee arthroplasty. Participants were randomly assigned to one of three groups to assess the effects of intra-articular tranexamic acid and/or suction drainage on total and hidden blood loss, transfusion requirements, postoperative limb swelling, wound-related complications, and knee range of motion.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid with Suction Drainage | Experimental | Drug: Intra-articular Tranexamic Acid + Suction DrainagePatients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. A closed suction drain was inserted intra-articularly and subcutaneously, activated two hours postoperatively. |
| Tranexamic Acid without Drainage | Experimental | Drug: Intra-articular Tranexamic AcidPatients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. No suction drain was used in this group. |
| Suction Drainage without Tranexamic Acid | Active comparator | Device: Suction Drainage OnlyPatients undergoing total knee arthroplasty had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered in this group. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with degenerative knee arthritis
- Scheduled for unilateral total knee arthroplasty
Key exclusion criteria (5 listed)
- Rheumatoid arthritis
- Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events)
- Coagulation disorders or thromboembolic disorders
- Severe infections
- Other serious health issues
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 |
|---|---|---|
| Intra-articular Tranexamic Acid + Suction DrainagePatients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. | Drug | Tranexamic Acid with Suction Drainage |
| Intra-articular Tranexamic AcidPatients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used. | Drug | Tranexamic Acid without Drainage |
| Suction Drainage OnlyPatients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered. | Device | Suction Drainage without Tranexamic Acid |
Primary outcome
Total Blood Loss
Time frame: Within 72 hours after surgery
Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula.
7 secondary outcomes
Hidden Blood Loss
Time frame: Within 72 hours after surgery
Drainage Volume
Time frame: 24 hours postoperatively
Number of Blood Transfusions
Time frame: During hospital stay (up to 7 days postoperatively)
Postoperative Limb Swelling
Time frame: 1, 2, 4, and 6 weeks postoperatively
Wound-related Complications
Time frame: Within 6 weeks after surgery
Thromboembolic Events (DVT/PE)
Time frame: Within 6 weeks after surgery
Postoperative Knee Range of Motion
Time frame: 2 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- BackgroundZhou C, Gao X, Han H, Wang L, Jiang H. The efficacy and safety of tranexamic acid in primary total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024;19(1):37. doi:10.1177/15563316231208716.
- Background: PubMed 42023914Gonzalez-Pola R, Tafoya-Olivos RO, Culebras-Almeida LA, Zermeno-Garcia G, Herrera-Lozano A. Minimizing bleeding and transfusion in single-stage bilateral hip and knee arthroplasty: A systematic review of current interventions. Rev Esp Cir Ortop Traumatol. 2025 Sep-Oct;69(5):532-543. doi: 10.1016/j.recot.2025.04.017. Epub 2025 May 7. English, Spanish.
- Results publication: PubMed 35109837Hishimura R, Onodera T, Ohkoshi Y, Okada K, Matsuoka M, Matsubara S, Iwasaki K, Kondo E, Iwasaki N. The effect of local injection of tranexamic acid into peri-articular tissue versus drain clamping in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 2;23(1):111. doi: 10.1186/s12891-022-05058-6.
- Results publication: PubMed 36143903Kim MK, Ko SH, Nam YC, Jeon YS, Kwon DG, Ryu DJ. Optimal Release Timing of Drain Clamping to Reduce Postoperative Bleeding after Total Knee Arthroplasty with Intraarticular Injection of Tranexamic Acid. Medicina (Kaunas). 2022 Sep 5;58(9):1226. doi: 10.3390/medicina58091226.
- Results publication: PubMed 38138181Liu CH, Chang CH, Chang YH, Shih HN, Hu CC. Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty-A Prospective Randomized Controlled Trial. Medicina (Kaunas). 2023 Nov 26;59(12):2078. doi: 10.3390/medicina59122078.
- Results publicationZhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of hypotensive anesthesia and regional anesthesia on intraoperative blood loss in total knee arthroplasty. World J Emerg Surg. 2024;19(1):33. doi:10.1186/s13017-024-00554-7
- Results publication: PubMed 39548417Chaiyakit P, Kabkaew P, Hongku N, Wattanapreechanon P. Comparison of total blood loss between limited tourniquet use and conventional tourniquet use in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Nov 15;25(1):918. doi: 10.1186/s12891-024-08058-w.
- Results publication: PubMed 38858713Liu Y, Ai J, Teng X, Huang Z, Wu H, Zhang Z, Wang W, Liu C, Zhang H. Risk factor analysis and establishment of a nomogram model to predict blood loss during total knee arthroplasty. BMC Musculoskelet Disord. 2024 Jun 10;25(1):459. doi: 10.1186/s12891-024-07570-3.
- Results publicationShih CH, Hsu CL, Lin YC, Lee MS, Huang TL, Chang JK. The role of tranexamic acid and cryotherapy on acute postoperative pain and blood loss in total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025;20(1):141. doi:10.1186/s13018-025-03744-6.
- Results publication: PubMed 40529153Liangliang L, Wei H, Tao Z, Pin P, Lianying H. Efficacy and safety of tranexamic acid in reducing hidden blood loss during unilateral total knee arthroplasty: a retrospective study. Front Med (Lausanne). 2025 Jun 3;12:1552893. doi: 10.3389/fmed.2025.1552893. eCollection 2025.
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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.
Mhmoud Adnan Al-Salamah principal investigator
Idlib University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular Tranexamic Acid + Suction Drainage, Intra-articular Tranexamic Acid and Suction Drainage Only in people with Osteoarthritis, Knee, run by Idlib University at 1 site in Syria.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Blood Loss (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174895, which also lists 10 linked publications.
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 16 Sep 2025.