Traumatic Brain InjuryPhase 3TOPHR HITNCT01642524
The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)
A Phase 3 study testing hypertonic saline mixed Dextran and Saline solution in people with Traumatic Brain Injury, run by Sunnybrook Health Sciences Centre.
Trial summary
The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- hypertonic saline mixed Dextran and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jul 2011
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥16
- Initial assessment of Glasgow Coma Score (GCS) 8 or less
- Blunt traumatic mechanism of injury
Who cannot join
- Known pregnancy
- Penetrating primary injury
- VSA prior to randomization; previous intravenous therapy ≥ 50 ml
- Time interval between arrival at scene and intravenous access exceeds four hours
- Amputation of above wrist or ankle
- Any burn (thermal, chemical, electrical, radiation)
- Suspected hypothermia
- Asphyxia (strangulation, hanging, choking, suffocation, drowning) and fall from height ≤ 1m or ≤ 5 stairs.
About this study
Official title: The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.
Read the detailed description
Study Objective
The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds, specifically addressing:
- baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
- randomization compliance rate.
- ease of protocol implementation in the out-of-hospital setting.
- adverse rate of Hypertonic Saline Dextran (HSD) infusion.
The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.
- Conditions
- Traumatic Brain Injury
- Being tested
- hypertonic saline mixed Dextran, Saline solution
- Keywords
- resuscitation
- 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.
hypertonic saline mixed DextranBiological
single dose administered intravenously
Saline solutionBiological
placebo - saline solution
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline mixed Dextran | Experimental | hypertonic saline mixed Dextran Receives: Biological: hypertonic saline mixed Dextran |
| Placebo controlled | Placebo comparator | Saline solution Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day survival
Measured: 30 days after discharge
Secondary outcomes (7)
Survival
•Survival: 48 hours after admission; Hospital discharge
Measured: 48 hrs after admission
Functional neurological outcomes at 4 months
Measured: 4 Months
Neuropsychological testing at 4 months
Measured: 4 months
Neuropsychological testing at 1 year
Measured: 1 year
Physiologic parameters indicative of organ dysfunction
Measured: 4 months
Structural parameters indicative of brain injury or dysfunction at 4 months
Measured: 4 months
Serum inflammatory markers measured on arrival, 12, 24, 48 hours later
Measured: 12, 24, 48 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startApr 2004
- Primary completionJan 2006
- Study completionJul 2011
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 Sunnybrook Health Sciences CentreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Defence Research and Development Canada
- Responsible party
- Principal investigator, Dr. Laurie Morrison, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642524
- Sponsor's protocol ID
- TOPHR HIT
- Acronym
- TOPHR HIT
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
- ClinicalTrials.gov ID
- NCT01642524
- Acronym / sponsor ID
- TOPHR HIT / TOPHR HIT
- Conditions
- Traumatic Brain Injury
- Keywords
- resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Defence Research and Development Canada
- Study start
- Apr 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jul 2012 (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 TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.
Detailed description
Study Objective
The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds, specifically addressing:
- baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
- randomization compliance rate.
- ease of protocol implementation in the out-of-hospital setting.
- adverse rate of Hypertonic Saline Dextran (HSD) infusion.
The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic saline mixed Dextran | Experimental | Biological: hypertonic saline mixed Dextranhypertonic saline mixed Dextran |
| Placebo controlled | Placebo comparator | Biological: Saline solutionSaline solution |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥16
- Initial assessment of Glasgow Coma Score (GCS) 8 or less
- Blunt traumatic mechanism of injury
Key exclusion criteria (8 listed)
- Known pregnancy
- Penetrating primary injury
- VSA prior to randomization; previous intravenous therapy ≥ 50 ml
- Time interval between arrival at scene and intravenous access exceeds four hours
- Amputation of above wrist or ankle
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 |
|---|---|---|
| hypertonic saline mixed Dextransingle dose administered intravenously | Biological | hypertonic saline mixed Dextran |
| Saline solutionplacebo - saline solution | Biological | Placebo controlled |
Primary outcome
30 day survival
Time frame: 30 days after discharge
7 secondary outcomes
Survival
Time frame: 48 hrs after admission
Functional neurological outcomes at 4 months
Time frame: 4 Months
Neuropsychological testing at 4 months
Time frame: 4 months
Neuropsychological testing at 1 year
Time frame: 1 year
Physiologic parameters indicative of organ dysfunction
Time frame: 4 months
Structural parameters indicative of brain injury or dysfunction at 4 months
Time frame: 4 months
Serum inflammatory markers measured on arrival, 12, 24, 48 hours later
Time frame: 12, 24, 48 hours later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hypertonic saline mixed Dextran and Saline solution in people with Traumatic Brain Injury, run by Sunnybrook Health Sciences Centre.
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 3 inclusion and 8 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 17 Jul 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 day survival (time frame: 30 days after discharge). 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 17 Jul 2012.