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

Traumatic Brain Injury Clinical Trial

— TOPHR HIT  

Official title:

The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642524
• Other study ID #: TOPHR HIT
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2012
• Last updated: July 13, 2012
• Start date: April 2004
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canada Therapeutics Products Directorate Registration Number 092523
• Study type: Interventional

Clinical 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. 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2011
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Traumatic Brain Injury

Intervention

Biological:
• hypertonic saline mixed Dextran
single dose administered intravenously
• Saline solution
placebo - saline solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Defence Research and Development Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day survival		30 days after discharge	No
Secondary	Survival	•Survival: 48 hours after admission; Hospital discharge	48 hrs after admission	No
Secondary	Functional neurological outcomes at 4 months		4 Months	No
Secondary	Neuropsychological testing at 4 months		4 months	No
Secondary	Neuropsychological testing at 1 year		1 year	No
Secondary	Physiologic parameters indicative of organ dysfunction		4 months	No
Secondary	Structural parameters indicative of brain injury or dysfunction at 4 months		4 months	No
Secondary	Serum inflammatory markers measured on arrival, 12, 24, 48 hours later		12, 24, 48 hours later	No