NCT00878631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

April 9, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

April 8, 2009

Last Update Submit

April 8, 2009

Conditions

Brain Injuries

Keywords

emergency medical servicestraumatic brain injuryhypertonic saline with dextranfluid resuscitation

Outcome Measures

Primary Outcomes (4)

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

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

  • randomization compliance rate

    duration of enrolment

  • ease of protocol implementation in the out-of-hospital setting

    duration of study

  • adverse event rate of hypertonic saline dextran infusion

    duration of study

Secondary Outcomes (4)

  • 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

    discharge and at 4 months post incident

  • 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.

    at 4 and 12 months post incident

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

    4 months post incident

  • 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

    samples taken within 48 hours of incident

Study Arms (2)

1 Normal Saline

ACTIVE COMPARATOR

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

Drug: Normal Saline

2 - hypertonic saline mixed with dextran

EXPERIMENTAL

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

Drug: hypertonic saline mixed with dextran

Interventions

hypertonic saline mixed with dextranDRUG

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

Also known as: RescueFlow BioPhausia AB, Stockholm Sweden
2 - hypertonic saline mixed with dextran
Normal SalineDRUG

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

1 Normal Saline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5V 1W8, Canada

Location

Related Publications (4)

  • 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.

    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.

    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.

    PMID: 20082712DERIVED

  • 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.

    PMID: 19930566DERIVED

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Interventions

DextransSaline Solution

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

September 1, 2004

Primary Completion

January 1, 2006

Study Completion

December 1, 2008

Last Updated

April 9, 2009

Record last verified: 2009-04

Locations

CA(2)