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

NCT ID: NCT00878631

Last Updated: 2009-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-12-31

Brief 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 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 Normal Saline

infusion of 250 ccs of Normal Saline within 4 hours of the accident

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

2 - hypertonic saline mixed with dextran

a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 infused within 4 hours of the accident

Group Type: EXPERIMENTAL

hypertonic saline mixed with dextran

Intervention Type: DRUG

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

Interventions

hypertonic saline mixed with dextran

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

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Other Intervention Names

RescueFlow BioPhausia AB, Stockholm Sweden

Eligibility Criteria

Inclusion Criteria

• Age ≥ 16;
• Initial assessment of GCS 8 or less;
• Blunt traumatic mechanism of injury.

Exclusion Criteria

• 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;
• Any burn (thermal, chemical, electrical, radiation)
• Suspected hypothermia;
• Asphyxia (strangulation, hanging, choking, suffocation, drowning)
• Fall from height ≤ 1m or ≤ 5 Stairs

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Center, Toronto

UNKNOWN

Sponsor Role: collaborator

Defence Research and Development Canada

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

St Michael's Hospital

Locations

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 20082712 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19930566 (View on PubMed)

Other Identifiers

No.w7711-027801/001/TOR

Identifier Type: -

Identifier Source: secondary_id

TOPHR HIT

Identifier Type: -

Identifier Source: org_study_id