ScoliosisNCT06091891
Tranexamic Acid in Pediatric Scoliosis Surgery
A study testing Tranexamic acid and Tranexamic acid infusion under ROTEM-guidance in people with Scoliosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Tranexamic acid and Tranexamic acid infusion under ROTEM-guidance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2023to 1 Sep 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children undergoing scoliosis surgery under the age of 18
Who cannot join
- Patients with coagulation disorders
- Patients at an increased risk of thrombosis
- Patients with a history of epilepsy or brain surgery
- Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid
- Severe liver or kidney impairment
- Other cases deemed inappropriate by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul, 03080
Eun-hee Kim, 820220723664 ext. 82, beloveun@snu.ac.kr
About this study
Official title: Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.
- Conditions
- Scoliosis
- Being tested
- Tranexamic acid, Tranexamic acid infusion under ROTEM-guidance
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
Tranexamic acid infusion under ROTEM-guidanceDrug
If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Drug: Tranexamic acid |
| ROTEM-guided | Experimental | Not described Receives: Drug: Tranexamic acid infusion under ROTEM-guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding loss
total volume of blood loss during surgery determined by anesthesiologist
Measured: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Secondary outcomes (8)
RBC blood transfusion
intraoperative red blood cell volume of transfused during surgery per hour
Measured: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
urine output
intraoperative total urine output during surgery per hour
Measured: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Other blood transfusion
Volume of blood cells transfused during surgery per hour, such as FFP, platelets, and cryoprecipitates.
Measured: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative viscoelastic whole blood profile
CT, CFT, A10, MCF, ML in EXTEM and CT, CFT, A10, MCF, ML in FIBTEM at the end of surgery
Measured: 1 hours from the end of surgery
JP drain
total JP drain for 24 hours after the end of surgery
Measured: 24 hours from the end of surgery
IL-6
the change in IL-6 values before and after surgery
Measured: 1 hours from the end of surgery
total tranexamic acid dose
Total amount of tranexamic acid used during surgery
Measured: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative complications
Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.
Measured: 2 weeks from the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start16 Oct 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
- Investigators
- Jung-Bin Park, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091891
- Sponsor's protocol ID
- 2308-113-1459
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06091891
- Acronym / sponsor ID
- 2308-113-1459
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Oct 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.
This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Tranexamic acid |
| ROTEM-guided | Experimental | Drug: Tranexamic acid infusion under ROTEM-guidance |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children undergoing scoliosis surgery under the age of 18
Key exclusion criteria (6 listed)
- Patients with coagulation disorders
- Patients at an increased risk of thrombosis
- Patients with a history of epilepsy or brain surgery
- Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid
- Severe liver or kidney impairment
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 acidWithout ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery. | Drug | Control |
| Tranexamic acid infusion under ROTEM-guidanceIf diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results. | Drug | ROTEM-guided |
Primary outcome
intraoperative bleeding loss
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
total volume of blood loss during surgery determined by anesthesiologist
8 secondary outcomes
RBC blood transfusion
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
urine output
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Other blood transfusion
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative viscoelastic whole blood profile
Time frame: 1 hours from the end of surgery
JP drain
Time frame: 24 hours from the end of surgery
IL-6
Time frame: 1 hours from the end of surgery
total tranexamic acid dose
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative complications
Time frame: 2 weeks from the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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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.
Jung-Bin Park study director
Seoul National University Hospital
1 site 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 Tranexamic acid infusion under ROTEM-guidance in people with Scoliosis, run by Seoul National University Hospital 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 1 inclusion and 6 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 19 Oct 2023. 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.
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 Jung-Bin Park (820220723664, jb4001@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative bleeding loss (time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)). 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 19 Oct 2023.