Arthritis KneePhase 4NCT05957822
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
A Phase 4 study testing TXA and TEG6 in people with Arthritis Knee and Spine Fusion, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee, Spine Fusion, Prostate Cancer
- What is being tested?
- TXA and TEG6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2024to 1 Jan 2025
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spinal fusion surgery with more than 2 levels
- total hip arthroplasty
- total knee arthroplasty
- open prostatectomy
- hepatectomy
Who cannot join
- pregnancy
- refusal of allogenic blood transfusion
- taking thrombin
- history of thromboembolic and familial hypercoagulability disease
- recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
- hypersensitive to TXA
Show all 9Show fewer
- histroy of convulsion or epilepsy
- taking hemodialysis
- history of Heparin-induced thrombocytopenia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, 143-729
Tae-yop Kim, M.D, PhD, taeyop@gmail.com
Tae-Yop Kim, MD PhD
About this study
Official title: Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
Read the detailed description
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.
- Conditions
- Arthritis Knee, Spine Fusion, Prostate Cancer, Arthritis of Hip, Hepatic Cancer
- Being tested
- TXA, TEG6
- Keywords
- bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure
- Medical subject headings
- Prostatic Neoplasms, Liver Neoplasms, Hemorrhage, Thromboembolism, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXADrug
Also called TXA administration
Tranexamic acid injection 8-10mg/kg
TEG6Diagnostic test
Also called thromboelastography 6
performing thromboelastography (TEG6)
| Study group | Role | What they receive |
|---|---|---|
| TXA empirical | Active comparator | Empirical Tranexamic acid (TXA) administration after the anesthesia induction Receives: Drug: TXA |
| TXA TEG6-triggered | Experimental | When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered Receives: Drug: TXA; Diagnostic Test: TEG6 |
| TXA TEG6-non-triggered | Experimental | When LY30<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered Receives: Diagnostic Test: TEG6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT maximal amplitude
maximal amplitude of CRT test
Measured: 24 hours
Secondary outcomes (13)
CK reaction time
value of r-time of CK test
Measured: 24 hours
CK alpha angle
value of alpha-angle of CK test
Measured: 24 hours
CRT maximal lysis
value of maximal lysis of CRT test
Measured: 24 hours
CFF maximal amplitude
value of maximal amplitude of CFF test
Measured: 24 hours
Hemoglobin
serum hemoglobin value
Measured: 24 hours
packed RBC
number of unit, transfused packed RBC
Measured: 6 hours
fresh frozen plasma
number of unit, transfused fresh frozen plasma
Measured: 6 hours
cryoprecipitate
number of unit, transfused cryoprecipitate
Measured: 6 hours
platelet
number of unit, transfused platelet (apheresis) or platelet concentrate
Measured: 6 hours
seizure
incidence of postoperative seizure
Measured: 48 hours
thromboembolism
incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Measured: 48 hours
postoperative bleeding
amount of bleeding from surgical drain
Measured: 48 hours
re-operation
incidence of re-operation due to postoperative bleeding
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start10 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized prospective multicenter non-inferior
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Asan Medical Center, Soon Chun Hyang University
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD, PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957822
- Sponsor's protocol ID
- HI22C195200-1-1
- Status last verified
- May 2024
- First submitted
- 7 Jul 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT05957822
- Acronym / sponsor ID
- HI22C195200-1-1
- Conditions
- Arthritis Knee, Spine Fusion, Prostate Cancer, Arthritis of Hip, Hepatic Cancer
- Keywords
- bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Asan Medical Center, Soon Chun Hyang University
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Jul 2023 (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 present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
Detailed description
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized prospective multicenter non-inferior
| Arm | Type | Receives |
|---|---|---|
| TXA empirical | Active comparator | Drug: TXAEmpirical Tranexamic acid (TXA) administration after the anesthesia induction |
| TXA TEG6-triggered | Experimental | Drug: TXA, Diagnostic Test: TEG6When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered |
| TXA TEG6-non-triggered | Experimental | Diagnostic Test: TEG6When LY30<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- spinal fusion surgery with more than 2 levels
- total hip arthroplasty
- total knee arthroplasty
- open prostatectomy
- hepatectomy
Key exclusion criteria (9 listed)
- pregnancy
- refusal of allogenic blood transfusion
- taking thrombin
- history of thromboembolic and familial hypercoagulability disease
- recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
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 |
|---|---|---|
| TXAAlso: TXA administrationTranexamic acid injection 8-10mg/kg | Drug | TXA TEG6-triggered, TXA empirical |
| TEG6Also: thromboelastography 6performing thromboelastography (TEG6) | Diagnostic test | TXA TEG6-non-triggered, TXA TEG6-triggered |
Primary outcome
CRT maximal amplitude
Time frame: 24 hours
maximal amplitude of CRT test
13 secondary outcomes
CK reaction time
Time frame: 24 hours
CK alpha angle
Time frame: 24 hours
CRT maximal lysis
Time frame: 24 hours
CFF maximal amplitude
Time frame: 24 hours
Hemoglobin
Time frame: 24 hours
packed RBC
Time frame: 6 hours
fresh frozen plasma
Time frame: 6 hours
cryoprecipitate
Time frame: 6 hours
platelet
Time frame: 6 hours
seizure
Time frame: 48 hours
thromboembolism
Time frame: 48 hours
postoperative bleeding
Time frame: 48 hours
re-operation
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes
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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.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TXA and TEG6 in people with Arthritis Knee and Spine Fusion, run by Konkuk University Medical Center at 1 site in South Korea.
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 5 inclusion and 9 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 14 May 2024. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tae-Yop Kim (+82 10 8811 6942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT maximal amplitude (time frame: 24 hours). 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 14 May 2024.