Arthritis of HipNCT05956769
Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
A study testing Tranexamic Acid and thromboelastography in people with Arthritis of Hip, run by Konkuk University Medical Center at 2 sites in South Korea.
Trial summary
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding 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 of Hip
- What is being tested?
- Tranexamic Acid and thromboelastography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Feb 2024to 31 Dec 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- total hip arthroplasty
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
2 sites in 1 country.
South Korea2 sites
Konkuk University Medical Center
Seoul, 143-729
Soi Lee
Seoul
About this study
Official title: Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the 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.
- Conditions
- Arthritis of Hip
- Being tested
- Tranexamic Acid, thromboelastography, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
thromboelastographyDiagnostic test
thromboelastography (TEG6)
PlaceboDrug
Also called Normal saline
Normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Empirical 2: TXA administration | Active comparator | Tranexamic acid administration, regardless of the result of TEG6. Receives: Drug: Tranexamic Acid; Diagnostic Test: thromboelastography |
| Goal-directed 1: Placebo administration | Experimental | Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 < 3% or MA > 54 mm in CRT of TEG6 Receives: Diagnostic Test: thromboelastography; Drug: Placebo |
| Goal-directed 2: TXA administration | Experimental | Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6 Receives: Drug: Tranexamic Acid; Diagnostic Test: thromboelastography |
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 (14)
CK reaction time
r-time of CRT test
Measured: 24 hours
CK alpha angle
alpha angle of CRT test
Measured: 24 hours
CRT maximal lysis
maximal lysis of CRT test
Measured: 24 hours
CFF maximal amplitude
maximal amplitude of CFF test
Measured: 24 hours
Hemoglobin
the lowest hemoglobin value before transfusion
Measured: 6 hours
packed RBC
transfused fresh frozen plasma
Measured: 6 hours
fresh frozen plasma
transfused fresh frozen plasma
Measured: 6 hours
cryoprecipitate
transfused cryoprecipitate
Measured: 6 hours
platelet
transfused platelet (apheresis) or platelet concentrate
Measured: 6 hours
seizure
postoperative incidence of seizure
Measured: 48 hours
thromboembolism
preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Measured: 48 hours
postoperative bleeding
bleeding from surgical drain
Measured: 48 hours
re-operation
re-operation due to postoperative bleeding
Measured: 48 hours
intraoperative bleeding
amount of intraoperative bleeding
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Feb 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of HipStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956769
- Sponsor's protocol ID
- HI22C195200-1-2
- Status last verified
- Dec 2023
- First submitted
- 12 Jul 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT05956769
- Acronym / sponsor ID
- HI22C195200-1-2
- Conditions
- Arthritis of Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 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 placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
| Arm | Type | Receives |
|---|---|---|
| Empirical 2: TXA administration | Active comparator | Drug: Tranexamic Acid, Diagnostic Test: thromboelastographyTranexamic acid administration, regardless of the result of TEG6. |
| Goal-directed 1: Placebo administration | Experimental | Diagnostic Test: thromboelastography, Drug: PlaceboNormal saline administration, according to the result of TEG6. . Placebo administration, at LY30 < 3% or MA > 54 mm in CRT of TEG6 |
| Goal-directed 2: TXA administration | Experimental | Drug: Tranexamic Acid, Diagnostic Test: thromboelastographyTranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total hip arthroplasty
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 |
|---|---|---|
| Tranexamic AcidTranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr | Drug | Empirical 2: TXA administration, Goal-directed 2: TXA administration |
| thromboelastographythromboelastography (TEG6) | Diagnostic test | Empirical 2: TXA administration, Goal-directed 1: Placebo administration, Goal-directed 2: TXA administration |
| PlaceboAlso: Normal salineNormal saline injection | Drug | Goal-directed 1: Placebo administration |
Primary outcome
CRT maximal amplitude
Time frame: 24 hours
maximal amplitude of CRT test
14 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: 6 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
intraoperative bleeding
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and thromboelastography in people with Arthritis of Hip, run by Konkuk University Medical Center at 2 sites 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 1 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
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 2 Jan 2024.