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CORTICOSTEROID RANDOMISATION AFTER SIGNIFICANT HEAD INJURY

CORTICOSTEROID RANDOMISATION AFTER SIGNIFICANT HEAD INJURY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-095-03
Enrollment
Unknown
Registered
2004-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Corticosteroids Type of group
1. Add 20cc. of water to inject to a 2 gr ampoule. and mix properly 2. Add the contents of the vial to the 100 cc bag. of NaCI 0.9% 3. Administer the infusion for 1 hour. Group name:Placebo Type of group
1. Add 20cc. of water to inject into a placebo ampoule and mix properly 2. Add the contents of the vial to the 100 cc bag. of NaCI 0.9% 3. Administer the infusion for 1 hour.

Sponsors

LONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients 16 years of age and older are eligible, with cranial trauma in which, in the absence of sedation, they obtain a score of 14 or less in the first 8 hours of the trauma. Although it is allowed to admit patients up to a maximum of 8 hours post-trauma.

Exclusion criteria

Exclusion criteria: The routine exclusion of patients with gastrointestinal disorders or pregnancy is unnecessary, unless the responsible physician considers that there is a definitive contraindication.

Design outcomes

Primary

MeasureTime frame
Outcome name:• Death from any cause within the first two weeks of trauma • Death or dependence six months after the trauma. Measure:Effects of corticosteroids on mortality or disability secondary to major acute cranial trauma. Timepoints:week two

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)