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The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)

NCT ID: NCT01642524

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2011-07-31

Brief Summary

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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

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Study Objective

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 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

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Traumatic Brain Injury

Keywords

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resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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hypertonic saline mixed Dextran

hypertonic saline mixed Dextran

Group Type EXPERIMENTAL

hypertonic saline mixed Dextran

Intervention Type BIOLOGICAL

single dose administered intravenously

Placebo controlled

Saline solution

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type BIOLOGICAL

placebo - saline solution

Interventions

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hypertonic saline mixed Dextran

single dose administered intravenously

Intervention Type BIOLOGICAL

Saline solution

placebo - saline solution

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥16
* Initial assessment of Glasgow Coma Score (GCS) 8 or less
* Blunt traumatic mechanism of injury

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Defence Research and Development Canada

INDUSTRY

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Laurie Morrison

Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TOPHR HIT

Identifier Type: -

Identifier Source: org_study_id