Severe Traumatic Brain InjuryPhase 2BOOST 2NCT00974259
Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
A Phase 2 study testing Management protocol based on pBrO2 and ICP values. and Management protocol based on ICP values only. in people with Severe Traumatic Brain Injury, run by University of Pennsylvania at 10 sites in United States.
Trial summary
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and survive the injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Management protocol based on pBrO2 and ICP values. and Management protocol based on ICP values only.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2009to Dec 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-penetrating traumatic brain injury
- Requirement for intracranial pressure monitoring according to Guidelines for the Management of Severe TBI, as operationalized below:
- GCS 3-8 (measured off sedatives or paralytics) with abnormal CT scan. If patient is intubated, motor GCS < 4 required.
- If CT scan normal, motor GCS < 4 (measured off sedatives or paralytics)
- Intoxication is not a reason for deferring ICP monitoring if above criteria are met.
- If the patient has a witnessed seizure, wait 30 minutes to evaluate GCS.
- Randomization and placement of monitors within 12 hours of injury.
- Males and females Age 18-70 years, English or Spanish speaking patients.
Who cannot join
- Specific clinical contraindications:
- GCS motor score > 4 with normal CT scan
- Bilaterally absent pupillary responses
- Laboratory contraindications per safety considerations:
- Coagulopathy that makes insertion of parenchymal monitors contraindicated (Platelets < 50,000/mL, INR > 1.4) (Enrollment allowed if coagulopathy can be corrected before 12 hour post-injury deadline).
- Pregnant females will be excluded. Blood test for pregnancy is a routine part of care in ED's. However, if not done, a urine or blood test will be done as a safety precaution after consent but prior to study treatment.
Show all 21Show fewer
- Monitoring with pBrO2 monitor prior to randomization.
- Clinical, demographic and other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
- Systemic sepsis at the time of screening
- Refractory hypotension (SBP < 70 mm Hg for > 30 minutes)
- Refractory systemic hypoxia (paO2 < 60 mm Hg on FiO2 < 0.5)
- Evidence of premorbid disabling conditions that interfere with outcome assessment. These include diagnosis of Alzheimer's disease, Parkinson's disease, multiple sclerosis, spinal cord injury with deficits, history of stroke, brain tumors, chronic use of medication for disabling neurologic or psychiatric disorder, or history of suicide attempt within the past year.
- Imminent death or current life-threatening disease
- Prisoner
- Individuals who hold religious beliefs against blood transfusion
- Previous TBI hospitalization greater than 1 day
- Patients who are unlikely to be available for follow-up interview, even by telephone. for example, patients who are homeless, illegal aliens, or live in foreign countries and those with whom future personal (including family) or telephone contact is unlikely.
- Active drug or alcohol use or dependence that, in the opinion of the stie investigator, would interfere with follow-up.
- Imminent death or current life-threatening disease
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
- Participation in other observational or interventional clinical trials is allowed as long as the PI of each study agree ahead of time to allow co-enrollment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Cincinnati
Cincinnati, Ohio
Ohio State University
Columbus, Ohio
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Phase 2, Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen Monitoring in the Management of Severe Traumatic Brain Injury.
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and survive the injury. As a result, 80,000-90,000 people experience permanent disability associated with TBI. This project is designed to determine whether a device designed to measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially treatable shows promise in reducing the duration of brain ischemia, and to obtain information required to conduct a definitive clinical trial of efficacy.
A recently approved device makes it feasible to directly and continuously monitor the partial pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that episodes of low pBrO2 are common and are associated with a poor outcome, and that medical interventions are effective in improving pBrO2 in clinical practice. However, as there have been no randomized controlled trials carried out to determine whether pBrO2 monitoring results in improved outcome after severe TBI, use of this technology has not so far been widely adopted in neurosurgical intensive care units (ICUs). This study is the first randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at treating pBrO2, and feasibility of standardizing a complex intensive care unit management protocol across multiple clinical sites.
Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Parkland Memorial Hospital, the University of Washington/Harborview Medical Center, the University of Miami/Jackson Memorial Hospital, and the University of Pennsylvania/Hospital of the University of Pennsylvania. Functional outcome will be assessed at 6-months after injury.
Read the detailed description
Design and Outcomes
This study is a two-arm, single-blind, randomized, controlled, phase II, multi-center pilot trial of the efficacy of pBrO2 monitoring, and is designed to obtain data required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at normalizing pBrO2. 182 patients with severe TBI who require ICP monitoring will be recruited into this study at 4 clinical sites in the US (Univ. of Texas Southwestern/Parkland Memorial Hospital, Univ. of Washington/Harborview Medical Center, Univ. of Miami/Jackson Memorial Hospital, and Univ. of Pennsylvania/Hospital of the Univ. of Pennsylvania). All patients will have both ICP monitors and pBrO2 monitors inserted through the same burr hole. Half of the patients will be randomized to a treatment protocol based on both ICP and pBrO2 readings, while the control group will be randomized to a treatment protocol based only on ICP readings. The pBrO2monitors of the control arm will be masked, so that the treating physicians will be unaware of the pBrO2 information. Patients will have telephone follow-up interview to assess their level of recovery 6 months post injury, using the Glasgow Outcome Scale-Extended.
Interventions and Duration
Patients randomized to the control group will have pBrO2 implanted in a similar fashion as patients in the treatment group, but after calibration of the device, the display will be covered with opaque tape. Patients in the control will be treated with a protocol based on ICP measures only. Patients in the treatment group (both ICP and pBrO2 measures are visible) will be treated according to a protocol that incorporates both ICP and pBrO2 measures. The treatment protocols are based on current standards of care, but are described in detail to insure uniformity in treatments across the 4 study sites.
The probe will remain in place for a maximum or 5 days, until all values are normal for 48 hours, or sooner if a complication arises. If the patient has normal values, monitors will be removed after 48 hours.
Objectives
Primary Objective: The prescribed treatment protocol, based on pBrO2 monitoring, results in reduction of the fraction of time that brain oxygen levels are below the critical threshold of 20 mm Hg in patients with severe traumatic brain injury.
Secondary Objectives:
- Safety hypotheses: Adverse events associated with pBrO2 monitoring are rare.
- Feasibility hypotheses: Episodes of decreased pBrO2 can be identified and treatment protocol instituted comparably across 4 clinical sites, and protocol violations will be low (<10%) and uniform across different clinical sites.
- Non-futility hypothesis: A relative risk of good outcome measured by the Glasgow Outcome Scale-Extended 6 months after injury of 2.0 is consistent with the results of this phase II study.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Management protocol based on pBrO2 and ICP values., Management protocol based on ICP values only.
- Keywords
- Hypoxia, Ischemia, Intracranial hypertension, Neurocritical care
- Medical subject headings
- Brain Injuries, Traumatic, Hypoxia, Ischemia, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management protocol based on pBrO2 and ICP values.Device
Also called Licox, Camino
For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time.
Management protocol based on ICP values only.Device
Also called Camino
For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant.
| Study group | Role | What they receive |
|---|---|---|
| pBrO2 and ICP management | Experimental | Treatment protocol based on pBrO2 and ICP values. Receives: Device: Management protocol based on pBrO2 and ICP values. |
| ICP management | Active comparator | Treatment protocol based on ICP values only. Receives: Device: Management protocol based on ICP values only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg .
Proportion of time PbtO2 below 20 mm Hg
Measured: 5 days
Secondary outcomes (3)
Total Number Participants With Adverse Events Associated With PbtO2 Monitoring.
Total number participants with PbtO2 directed intervention-related Serious Adverse Events
Measured: 5 days
Adherence to PbtO2 and ICP-directed Treatment Protocol
Number of protocol deviations and violations for ICP/PbtO2 group and ICP only group.
The unit of measure for this outcome is number of events, where an event can be either a deviation or a violation.
Measured: 5 days
Relative Risk of Good Outcome of ICP/PbtO2 Group Compared to ICP Only Group.
Dichotomized Glagow Outcome Score-Extended:
GOSE 1-4 = Poor Outcome GOSE 5-8 = Good Outcome GOSE is a 8-point scale, with 1 = death, 8 = full recovery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2014
- Study completionDec 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Miami, University of Pittsburgh, Duke University, Ohio State University, Temple University, Thomas Jefferson University, University of Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Ramon Diaz-Arrastia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974259
- Sponsor's protocol ID
- R01NS061860
- Other IDs
- R01NS061860, R01NS061860-01A2
- Acronym
- BOOST 2
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2009
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial. Crit Care Med. 2017 Nov;45(11):1907-1914. doi: 10.1097/CCM.0000000000002619.
PubMed 29028696
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen Monitoring in the Management of Severe Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT00974259
- Acronym / sponsor ID
- BOOST 2 / R01NS061860
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- Hypoxia, Ischemia, Intracranial hypertension, Neurocritical care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Washington, University of Miami, University of Pittsburgh, Duke University, Ohio State University, Temple University, Thomas Jefferson University, University of Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 26 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and survive the injury. As a result, 80,000-90,000 people experience permanent disability associated with TBI. This project is designed to determine whether a device designed to measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially treatable shows promise in reducing the duration of brain ischemia, and to obtain information required to conduct a definitive clinical trial of efficacy.
A recently approved device makes it feasible to directly and continuously monitor the partial pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that episodes of low pBrO2 are common and are associated with a poor outcome, and that medical interventions are effective in improving pBrO2 in clinical practice. However, as there have been no randomized controlled trials carried out to determine whether pBrO2 monitoring results in improved outcome after severe TBI, use of this technology has not so far been widely adopted in neurosurgical intensive care units (ICUs). This study is the first randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at treating pBrO2, and feasibility of standardizing a complex intensive care unit management protocol across multiple clinical sites.
Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Parkland Memorial Hospital, the University of Washington/Harborview Medical Center, the University of Miami/Jackson Memorial Hospital, and the University of Pennsylvania/Hospital of the University of Pennsylvania. Functional outcome will be assessed at 6-months after injury.
Detailed description
Design and Outcomes
This study is a two-arm, single-blind, randomized, controlled, phase II, multi-center pilot trial of the efficacy of pBrO2 monitoring, and is designed to obtain data required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at normalizing pBrO2. 182 patients with severe TBI who require ICP monitoring will be recruited into this study at 4 clinical sites in the US (Univ. of Texas Southwestern/Parkland Memorial Hospital, Univ. of Washington/Harborview Medical Center, Univ. of Miami/Jackson Memorial Hospital, and Univ. of Pennsylvania/Hospital of the Univ. of Pennsylvania). All patients will have both ICP monitors and pBrO2 monitors inserted through the same burr hole. Half of the patients will be randomized to a treatment protocol based on both ICP and pBrO2 readings, while the control group will be randomized to a treatment protocol based only on ICP readings. The pBrO2monitors of the control arm will be masked, so that the treating physicians will be unaware of the pBrO2 information. Patients will have telephone follow-up interview to assess their level of recovery 6 months post injury, using the Glasgow Outcome Scale-Extended.
Interventions and Duration
Patients randomized to the control group will have pBrO2 implanted in a similar fashion as patients in the treatment group, but after calibration of the device, the display will be covered with opaque tape. Patients in the control will be treated with a protocol based on ICP measures only. Patients in the treatment group (both ICP and pBrO2 measures are visible) will be treated according to a protocol that incorporates both ICP and pBrO2 measures. The treatment protocols are based on current standards of care, but are described in detail to insure uniformity in treatments across the 4 study sites.
The probe will remain in place for a maximum or 5 days, until all values are normal for 48 hours, or sooner if a complication arises. If the patient has normal values, monitors will be removed after 48 hours.
Objectives
Primary Objective: The prescribed treatment protocol, based on pBrO2 monitoring, results in reduction of the fraction of time that brain oxygen levels are below the critical threshold of 20 mm Hg in patients with severe traumatic brain injury.
Secondary Objectives:
- Safety hypotheses: Adverse events associated with pBrO2 monitoring are rare.
- Feasibility hypotheses: Episodes of decreased pBrO2 can be identified and treatment protocol instituted comparably across 4 clinical sites, and protocol violations will be low (<10%) and uniform across different clinical sites.
- Non-futility hypothesis: A relative risk of good outcome measured by the Glasgow Outcome Scale-Extended 6 months after injury of 2.0 is consistent with the results of this phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pBrO2 and ICP management | Experimental | Device: Management protocol based on pBrO2 and ICP values.Treatment protocol based on pBrO2 and ICP values. |
| ICP management | Active comparator | Device: Management protocol based on ICP values only.Treatment protocol based on ICP values only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-penetrating traumatic brain injury
- Requirement for intracranial pressure monitoring according to Guidelines for the Management of Severe TBI, as operationalized below:
- Randomization and placement of monitors within 12 hours of injury.
- Males and females Age 18-70 years, English or Spanish speaking patients.
Key exclusion criteria (21 listed)
- Specific clinical contraindications:
- Laboratory contraindications per safety considerations:
- Coagulopathy that makes insertion of parenchymal monitors contraindicated (Platelets < 50,000/mL, INR > 1.4) (Enrollment allowed if coagulopathy can be corrected before 12 hour post-injury deadline).
- Pregnant females will be excluded. Blood test for pregnancy is a routine part of care in ED's. However, if not done, a urine or blood test will be done as a safety precaution after consent but prior to study treatment.
- Monitoring with pBrO2 monitor 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 |
|---|---|---|
| Management protocol based on pBrO2 and ICP values.Also: Licox, CaminoFor patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time. | Device | pBrO2 and ICP management |
| Management protocol based on ICP values only.Also: CaminoFor the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant. | Device | ICP management |
Primary outcome
Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg .
Time frame: 5 days
Proportion of time PbtO2 below 20 mm Hg
3 secondary outcomes
Total Number Participants With Adverse Events Associated With PbtO2 Monitoring.
Time frame: 5 days
Adherence to PbtO2 and ICP-directed Treatment Protocol
Time frame: 5 days
Relative Risk of Good Outcome of ICP/PbtO2 Group Compared to ICP Only Group.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29028696Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial. Crit Care Med. 2017 Nov;45(11):1907-1914. doi: 10.1097/CCM.0000000000002619.
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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.
10 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 Management protocol based on pBrO2 and ICP values. and Management protocol based on ICP values only. in people with Severe Traumatic Brain Injury, run by University of Pennsylvania at 10 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 8 inclusion and 21 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 26 Sep 2019). 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?
Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg . (time frame: 5 days). 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 NCT00974259, which also lists 1 linked publication.
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 26 Sep 2019.