Traumatic Brain InjuryPhase 2NCT00556387
Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
A Phase 2 study testing saline and Ketamine in people with Traumatic Brain Injury, run by University of Arkansas.
Trial summary
The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children. The researchers think that it will effect the outcomes of children with these injuries. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- saline and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2012
- Phase
- Phase 2
- 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 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- are 1 month to 16 years of age; AND
- are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
- are intubated and ventilated for the management of TBI; AND
- are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
- have an intra-cranial pressure (ICP) monitoring device for management of TBI.
Who cannot join
- are less than 4 kilograms in weight upon admission
- are less than 1 month of age;
- are greater than 16 years of age;
- have a clinical diagnosis of non-accidental TBI;
- have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
- have a known allergy to ketamine;
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- have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
- have a current history of neuromuscular disease;
- have a current history of hepatic failure;
- have a current history of glaucoma
- require chronic treatment with anti-epileptic drugs (AEDs) or devices;
- more than 8 hours have elapsed from the time of injury to PICU admission;
- have documentation of a positive pregnancy test at the time of enrollment;
- if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).
About this study
Official title: Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.
The researchers think that it will effect the outcomes of children with these injuries.
- Conditions
- Traumatic Brain Injury
- Being tested
- saline, Ketamine
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
KetamineDrug
1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Group receiving Saline Infusion. Receives: Drug: saline |
| 2 | Experimental | Case Group receiving Ketamine infusion. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.
Measured: 1 year
Secondary outcomes (1)
To compare the expression of biomarkers of CNS injury between cases and controls.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startDec 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Muayyad Tailounie, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556387
- Sponsor's protocol ID
- IRB 86674
- Other IDs
- 86674
- Status last verified
- Oct 2013
- First submitted
- 9 Nov 2007
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00556387
- Acronym / sponsor ID
- IRB 86674
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 12 Nov 2007 (estimated)
- 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 purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.
The researchers think that it will effect the outcomes of children with these injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: salinePlacebo Group receiving Saline Infusion. |
| 2 | Experimental | Drug: KetamineCase Group receiving Ketamine infusion. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- are 1 month to 16 years of age; AND
- are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
- are intubated and ventilated for the management of TBI; AND
- are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
- have an intra-cranial pressure (ICP) monitoring device for management of TBI.
Key exclusion criteria (14 listed)
- are less than 4 kilograms in weight upon admission
- are less than 1 month of age;
- are greater than 16 years of age;
- have a clinical diagnosis of non-accidental TBI;
- have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
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 |
|---|---|---|
| saline1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first) | Drug | 1 |
| Ketamine1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first) | Drug | 2 |
Primary outcome
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.
Time frame: 1 year
1 secondary outcome
To compare the expression of biomarkers of CNS injury between cases and controls.
Time frame: 96 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
Muayyad Tailounie, MD principal investigator
Arkansas Children's Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saline and Ketamine in people with Traumatic Brain Injury, run by University of Arkansas.
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 14 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: withdrawn, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. (time frame: 1 year). 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 1 Nov 2013.