Brain InjuriesPhase 2TIC-TOCNCT02840097
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study
A Phase 2 study testing Tranexamic Acid in people with Brain Injuries and Wounds and Injuries, run by Daniel Nishijima, MD, MAS at 4 sites in United States.
Trial summary
Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Brain Injuries, Wounds and Injuries, Hemorrhage
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Mar 2019to 3 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 18 years old AND
- Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
- Penetrating Torso Trauma:
- Penetrating trauma to the chest, abdomen, neck, pelvis or thigh with at least one of the following:
- age-adjusted hypotension, or
- age-adjusted tachycardia despite adequate resuscitation fluids, or
Show all 20Show fewer
- radiographic evidence of internal hemorrhage, or
- clinician suspicion of ongoing internal hemorrhage
- Blunt Torso Trauma (at least one of the following):
- Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:
- age-adjusted hypotension, or
- persistent age-adjusted tachycardia despite adequate resuscitation fluids
- Hemothorax on chest tube placement or imaging,
- Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
- Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,
- Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following:
- Age-adjusted tachycardia, or
- Age-adjusted hypotension.
- Head Trauma:
- Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)
Who cannot join
- Unable to administer study drug within 3 hours of traumatic event
- Known pregnancy
- Known prisoners
- Known wards of the state
- Cardiac arrest prior to randomization
- GCS score of 3 with bilateral unresponsive pupils
Show all 15Show fewer
- Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury
- Known bleeding/clotting disorders
- Known seizure disorders
- Known history of severe renal impairment
- Unknown time of injury
- Previous enrollment into the TIC-TOC trial
- Prior TXA for current injury
- Non-English and non-Spanish speaking
- Known venous or arterial thrombosis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, Davis
Sacramento, California, 95817
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Official title: Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): A Pilot and Feasibility Study
Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.
Read the detailed description
Tranexamic acid (TXA), a drug that stops bleeding, is the only drug treatment that improves survival in adults with serious bleeding after injuries. However, TXA has not been used routinely in children with traumatic bleeding because no studies have appropriately evaluated TXA for injured children. Such a study has the potential for significant impact in improving the lives of injured children and their families, if found to be successful. The long-term objective is to evaluate the benefits and risks of TXA in severely injured children. This will be achieved by ultimately conducting two large-scale, multicenter, randomized controlled trials of TXA use in severely injured children. One trial will evaluate TXA in children with severe injuries to the body ("torso injuries", i.e., to the abdomen and chest) and the second trial will evaluate TXA in children with moderate-to-severe traumatic brain injuries (TBIs). However, conducting a clinical trial in critically ill children is challenging due to lower disease frequency and complex parent consent/child assent procedures. The investigators will conduct a pilot study, designed similarly to the full-scale trials but with much smaller patient enrollment, to assess the feasibility of, and fill crucial information gaps for the two subsequent large-scale clinical trials. Injured children will be randomized to one of three study arms: two different TXA doses or placebo. The specific aim of the proposed pilot study is to demonstrate the ability to efficiently identify and enroll children with hemorrhagic torso injuries or TBIs into a multicenter, randomized controlled pilot study evaluating these two doses of TXA and placebo. The pilot study will enroll 40 children who meet inclusion and exclusion criteria at 4 participating sites. To demonstrate the ability to collect outcome measures, the investigators will collect the identical anticipated outcome measures for the subsequent clinical trials: total blood products transfused over the initial 48 hours of care (torso injury trial), and intracranial hemorrhage progression in first 24 hours and neurocognitive function at 6 months after randomization (TBI trial). The investigators will also collect safety outcomes, specifically venothromboembolic events (i.e., blot clots in the blood vessels) and seizures within the initial 24 hours of study drug. Additional objectives of this pilot study are to: evaluate the ability to efficiently screen, identify, consent, randomize, and initiate the study intervention within 3 hours of injury, assess protocol adherence and variability of care in enrolled patients, and identify operational efficiencies with the potential to enhance the success of the subsequent trials.
- Conditions
- Brain Injuries, Wounds and Injuries, Hemorrhage
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Brain injuries, Wounds and injuries, Hemorrhage, Tranexamic acid, Child
- Medical subject headings
- Brain Injuries, Wounds and Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
Active drug is provided to participants as described based on the TXA arm they are randomized to.
PlaceboDrug
Also called 0.9% Normal Saline
Normal saline is provided to participants if randomized to this treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid dose A | Experimental | Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA. Receives: Drug: Tranexamic Acid |
| Tranexamic acid dose B | Experimental | Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life Inventory (PedsQL)
Neurocognitive functioning and quality-of-life measures; range from 0 to 100 quality of life units with higher scores representing better outcomes. Measurements occur at 1 week, 1 month, 3 months, and 6 months to generate an area under the curve of quality of life units.
Measured: 6 months
Pediatric Quality of Life Inventory (PedsQL)
Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
Measured: 1 week, 1 month, 3 months, and 6 months
Secondary outcomes (7)
Glasgow Outcome Scale-Extended (GOS-E) Peds
Global functioning; range is 1 to 8 with higher scores representing better outcomes; 1=death, 2=vegetative state, 3=lower severe disability, 4=upper severe disability, 5=lower moderate disability, 6=upper moderate disability, 7=lower good recovery, 8=upper good recovery
Measured: 1 week, 1 month, 3 months, and 6 months
Digit Span Recall Test
Test of working memory; higher scores represent a better outcome, range from 0 to infinity
Measured: 1 week, 1 month, 3 months, and 6 months
Blood Transfusion
Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate
Measured: First 48 hours after randomization
Intracranial Hemorrhage Progression
Intracranial hemorrhage progression on cranial computed tomography (CT) imaging; hemorrhage will be measured using the ABC/2 volume estimation and relative to the total brain volume (calculated by the XYZ/2 volume estimation); more intracranial hemorrhage progression represents a worse outcome. Change is calculated as the difference between the baseline and repeat cranial CT imaging. The repeat CT is conducted 24 hours (±6 hours) after the baseline CT.
Measured: 24 hours (±6 hours)
Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis
Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization
Measured: Day 7 of hospitalization or hospital discharge (whichever comes first)
Number of Participants With Seizures
Clinical or electroencephalogram-documented
Measured: 24 hours after receiving drug
Biomarker Testing
Changes in coagulation biomarkers due to study intervention
Measured: Baseline and completion of 8 hour infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start4 Mar 2019
- Primary completion3 Oct 2020
- Study completion3 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Nishijima, MD, MAS
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network
- Responsible party
- Sponsor-investigator, Daniel Nishijima, MD, MAS, University of California, Davis
- Investigators
- Daniel K Nishijima, MD, MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840097
- Sponsor's protocol ID
- 1023599
- Acronym
- TIC-TOC
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2016
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nishijima DK, VanBuren J, Hewes HA, Myers SR, Stanley RM, Adelson PD, Barnhard SE, Bobinski M, Ghetti S, Holmes JF, Roberts I, Schalick WO 3rd, Tran NK, Tzimenatos LS, Michael Dean J, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network. Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. Trials. 2018 Oct 30;19(1):593. doi: 10.1186/s13063-018-2974-z.
PubMed 30376893Nishijima DK, Gosdin M, Naz H, Tancredi DJ, Hewes HA, Myers SR, Stanley RM, Adelson PD, Burd RS, Finkelstein Y, VanBuren J, Casper TC, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Assessment of primary outcome measures for a clinical trial of pediatric hemorrhagic injuries. Am J Emerg Med. 2021 May;43:210-216. doi: 10.1016/j.ajem.2020.03.001. Epub 2020 Mar 9.
PubMed 32278572Trappey AF 3rd, Thompson KM, Kuppermann N, Stephenson JT, Nuno MA, Hewes HA, Meyers SR, Stanley RM, Galante JM, Nishijima DK; Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process. J Trauma Acute Care Surg. 2019 Oct;87(4):935-943. doi: 10.1097/TA.0000000000002432.
PubMed 31299040Powers PE, Shore KK, Perez S, Ritley D, Kuppermann N, Holmes JF, Tzimenatos LS, Shawargga H, Nishijima DK. Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation. Acad Emerg Med. 2019 Oct;26(10):1158-1168. doi: 10.1111/acem.13827. Epub 2019 Jul 24.
PubMed 31271691Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17.
PubMed 35977357
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT02840097
- Acronym / sponsor ID
- TIC-TOC / 1023599
- Conditions
- Brain Injuries, Wounds and Injuries, Hemorrhage
- Keywords
- Brain injuries, Wounds and injuries, Hemorrhage, Tranexamic acid, Child
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Daniel Nishijima, MD, MASUniversity, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 3 Oct 2020 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.
Detailed description
Tranexamic acid (TXA), a drug that stops bleeding, is the only drug treatment that improves survival in adults with serious bleeding after injuries. However, TXA has not been used routinely in children with traumatic bleeding because no studies have appropriately evaluated TXA for injured children. Such a study has the potential for significant impact in improving the lives of injured children and their families, if found to be successful. The long-term objective is to evaluate the benefits and risks of TXA in severely injured children. This will be achieved by ultimately conducting two large-scale, multicenter, randomized controlled trials of TXA use in severely injured children. One trial will evaluate TXA in children with severe injuries to the body ("torso injuries", i.e., to the abdomen and chest) and the second trial will evaluate TXA in children with moderate-to-severe traumatic brain injuries (TBIs). However, conducting a clinical trial in critically ill children is challenging due to lower disease frequency and complex parent consent/child assent procedures. The investigators will conduct a pilot study, designed similarly to the full-scale trials but with much smaller patient enrollment, to assess the feasibility of, and fill crucial information gaps for the two subsequent large-scale clinical trials. Injured children will be randomized to one of three study arms: two different TXA doses or placebo. The specific aim of the proposed pilot study is to demonstrate the ability to efficiently identify and enroll children with hemorrhagic torso injuries or TBIs into a multicenter, randomized controlled pilot study evaluating these two doses of TXA and placebo. The pilot study will enroll 40 children who meet inclusion and exclusion criteria at 4 participating sites. To demonstrate the ability to collect outcome measures, the investigators will collect the identical anticipated outcome measures for the subsequent clinical trials: total blood products transfused over the initial 48 hours of care (torso injury trial), and intracranial hemorrhage progression in first 24 hours and neurocognitive function at 6 months after randomization (TBI trial). The investigators will also collect safety outcomes, specifically venothromboembolic events (i.e., blot clots in the blood vessels) and seizures within the initial 24 hours of study drug. Additional objectives of this pilot study are to: evaluate the ability to efficiently screen, identify, consent, randomize, and initiate the study intervention within 3 hours of injury, assess protocol adherence and variability of care in enrolled patients, and identify operational efficiencies with the potential to enhance the success of the subsequent trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid dose A | Experimental | Drug: Tranexamic AcidSubjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA. |
| Tranexamic acid dose B | Experimental | Drug: Tranexamic AcidSubjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Less than 18 years old AND
- Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
- Penetrating Torso Trauma:
- Blunt Torso Trauma (at least one of the following):
- Head Trauma:
Key exclusion criteria (15 listed)
- Unable to administer study drug within 3 hours of traumatic event
- Known pregnancy
- Known prisoners
- Known wards of the state
- Cardiac arrest prior to randomization
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 AcidAlso: TXAActive drug is provided to participants as described based on the TXA arm they are randomized to. | Drug | Tranexamic acid dose A, Tranexamic acid dose B |
| PlaceboAlso: 0.9% Normal SalineNormal saline is provided to participants if randomized to this treatment arm. | Drug | Placebo |
Primary outcome
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 6 months
Neurocognitive functioning and quality-of-life measures; range from 0 to 100 quality of life units with higher scores representing better outcomes. Measurements occur at 1 week, 1 month, 3 months, and 6 months to generate an area under the curve of quality of life units.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 1 week, 1 month, 3 months, and 6 months
Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
7 secondary outcomes
Glasgow Outcome Scale-Extended (GOS-E) Peds
Time frame: 1 week, 1 month, 3 months, and 6 months
Digit Span Recall Test
Time frame: 1 week, 1 month, 3 months, and 6 months
Blood Transfusion
Time frame: First 48 hours after randomization
Intracranial Hemorrhage Progression
Time frame: 24 hours (±6 hours)
Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis
Time frame: Day 7 of hospitalization or hospital discharge (whichever comes first)
Number of Participants With Seizures
Time frame: 24 hours after receiving drug
Biomarker Testing
Time frame: Baseline and completion of 8 hour infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30376893Nishijima DK, VanBuren J, Hewes HA, Myers SR, Stanley RM, Adelson PD, Barnhard SE, Bobinski M, Ghetti S, Holmes JF, Roberts I, Schalick WO 3rd, Tran NK, Tzimenatos LS, Michael Dean J, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network. Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. Trials. 2018 Oct 30;19(1):593. doi: 10.1186/s13063-018-2974-z.
- Results publication: PubMed 32278572Nishijima DK, Gosdin M, Naz H, Tancredi DJ, Hewes HA, Myers SR, Stanley RM, Adelson PD, Burd RS, Finkelstein Y, VanBuren J, Casper TC, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Assessment of primary outcome measures for a clinical trial of pediatric hemorrhagic injuries. Am J Emerg Med. 2021 May;43:210-216. doi: 10.1016/j.ajem.2020.03.001. Epub 2020 Mar 9.
- Results publication: PubMed 31299040Trappey AF 3rd, Thompson KM, Kuppermann N, Stephenson JT, Nuno MA, Hewes HA, Meyers SR, Stanley RM, Galante JM, Nishijima DK; Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process. J Trauma Acute Care Surg. 2019 Oct;87(4):935-943. doi: 10.1097/TA.0000000000002432.
- Results publication: PubMed 31271691Powers PE, Shore KK, Perez S, Ritley D, Kuppermann N, Holmes JF, Tzimenatos LS, Shawargga H, Nishijima DK. Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation. Acad Emerg Med. 2019 Oct;26(10):1158-1168. doi: 10.1111/acem.13827. Epub 2019 Jul 24.
- Derived from this study: PubMed 35977357Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17.
- TIC-TOC trial websiteLink provided by the sponsor.
- 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.
Daniel K Nishijima, MD, MAS principal investigator
University of California, Davis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Brain Injuries and Wounds and Injuries, run by Daniel Nishijima, MD, MAS at 4 sites in United States.
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 20 inclusion and 15 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pediatric Quality of Life Inventory (PedsQL) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02840097, which also lists 5 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 5 Sep 2021.