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Brain InjuriesPhase 2/3TOPHR HITNCT00878631

Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline

A Phase 2/3 study testing hypertonic saline mixed with dextran and Normal Saline in people with Brain Injuries, run by Unity Health Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Brain Injuries
What is being tested?
hypertonic saline mixed with dextran and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
2 sitesCanada
Study dates
Sep 2004to Dec 2008
Phase
Phase 2/3
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 GCS 8 or less;
  • Blunt traumatic mechanism of injury.

Who cannot join

  • Known pregnancy;
  • Primary injury penetrating;
  • VSA prior to randomization;
  • Previous Intravenous therapy ≥ 50 ml;
  • Time interval between arrival at scene and intravenous access exceeds four hours;
  • Amputation above wrist or ankle;
Show all 10Show fewer
  • Any burn (thermal, chemical, electrical, radiation)
  • Suspected hypothermia;
  • Asphyxia (strangulation, hanging, choking, suffocation, drowning)
  • Fall from height ≤ 1m or ≤ 5 Stairs

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • St Michael's Hospital

    Toronto, Ontario, M5V 1W8

Other trials in Canada

About this study

Official title: The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial

This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. The two solutions are a salt solution of different concentrations. One is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. This study is conducted without patient consent at the time of the study enrolment. The study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.

Read the detailed description

The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) is a randomized, placebo-controlled out of hospital trial of blunt trauma patients with head injuries. The study compares a group receiving normal saline according to a paramedic's protocol, with a treatment group receiving a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 (RescueFlow BioPhausia AB, Stockholm Sweden).

The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds*, specifically addressing:

  1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
  2. randomization compliance rate.
  3. ease of protocol implementation in the out-of-hospital setting.
  4. adverse rate of 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.

*Lancaster, G.A., S. Dodd, and P.R. Williamson, Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004. 10(2): p. 307-12.

Conditions
Brain Injuries
Being tested
hypertonic saline mixed with dextran, Normal Saline
Keywords
emergency medical services, traumatic brain injury, hypertonic saline with dextran, fluid resuscitation
Medical subject headings
Brain Injuries, 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 with dextranDrug

    Also called RescueFlow BioPhausia AB, Stockholm Sweden

    a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 is given within 4 hours from the time of the accident

  • Normal SalineDrug

    250 ccs of normal saline infused within 4 hours of the accident

Study groups in NCT00878631
Study groupRoleWhat they receive
1 Normal SalineActive comparatorinfusion of 250 ccs of Normal Saline within 4 hours of the accident
Receives: Drug: Normal Saline
2 - hypertonic saline mixed with dextranExperimentala single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 infused within 4 hours of the accident
Receives: Drug: hypertonic saline mixed with dextran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial

    Measured: survival at 48 hours, hospital discharge, 30 days and 4 months

  2. randomization compliance rate

    Measured: duration of enrolment

  3. ease of protocol implementation in the out-of-hospital setting

    Measured: duration of study

  4. adverse event rate of hypertonic saline dextran infusion

    Measured: duration of study

Secondary outcomes (4)

  1. neurocognitive outcomes at discharge (cerebral performance category) and at 4 months (functional independence measure, disability rating scale, Glasgow Outcome Scale and Glasgow outcome Scale Extended

    Measured: discharge and at 4 months post incident

  2. neuropsychological outcomes including learning and memory, working memory, executive function, language function, visuospatial function, speed of processing and Beck Depression Scale. A focused attention reaction time test was added to 12 month testing.

    Measured: at 4 and 12 months post incident

  3. magnetic resonance imaging to evaluate effects of HSD on brain atrophy post-injury

    Measured: 4 months post incident

  4. the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulation the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome

    Measured: samples taken within 48 hours of incident

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2009 (estimated)
  2. Study startSep 2004
  3. Primary completionJan 2006
  4. Study completionDec 2008

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00878631
Sponsor's protocol ID
TOPHR HIT
Other IDs
No.w7711-027801/001/TOR
Acronym
TOPHR HIT
Status last verified
Apr 2009
First submitted
8 Apr 2009
Last updated
9 Apr 2009
Results posted
No
Data monitoring committee
No

Publications

  • Morrison LJ, Rizoli S, Schwartz B, Rhind S, Black S, Stuss DT, Baker A, Univ of Toronto, Sunnybrook Health Sciences Centre, Toronto, Canada; on behalf of the TOPHR HIT Investigators. The Toronto Prehospital Resuscitation Head Injury and Multi-Organ Dysfunction Trial (TOPHR HIT). Circulation October 31, 2006; 114(18): #104.

  • Morrison LJ, Rizoli S, Schwartz B, Rhind S, Black S, Stuss DT, Baker A, Stuss DT, Baker A, Simitciu M, Perreira T, MacDonald RD. University of Toronto, Sunnybrook Health Sciences Center, Toronto, Canada; on behalf of the TOPHR HIT Investigators. The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi-Organ Dysfunction Trial (TOPHR HIT). Prehosp Emerg Care 2007; 11(1): 94.

  • Rhind SG, Crnko NT, Baker AJ, Morrison LJ, Shek PN, Scarpelini S, Rizoli SB. Prehospital resuscitation with hypertonic saline-dextran modulates inflammatory, coagulation and endothelial activation marker profiles in severe traumatic brain injured patients. J Neuroinflammation. 2010 Jan 18;7:5. doi: 10.1186/1742-2094-7-5.

    PubMed 20082712

  • Morrison LJ, Rizoli SB, Schwartz B, Rhind SG, Simitciu M, Perreira T, Macdonald R, Trompeo A, Stuss DT, Black SE, Kiss A, Baker AJ. The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT)--methods and data collection tools. Trials. 2009 Nov 20;10:105. doi: 10.1186/1745-6215-10-105.

    PubMed 19930566

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing hypertonic saline mixed with dextran and Normal Saline in people with Brain Injuries, run by Unity Health Toronto at 2 sites in Canada.

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 10 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 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 combined 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.

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?

baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial (time frame: survival at 48 hours, hospital discharge, 30 days and 4 months). The study lists 4 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 NCT00878631, which also lists 4 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 9 Apr 2009.

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