Randomised evaluation of surgery with craniectomie for uncontrollable elevation of intra-cranial pressure

Randomised evaluation of surgery with craniectomie for uncontrollable elevation of intra-cranial pressure - RESCUEicp

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33973

Enrollment

Registered

2010-06-07

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

intracranial pressure evelation

Interventions

(a) for unilateral hemisphere swelling / a large unilateral fronto-temporo-parietal craniectomy or (b) for bilateral diffuse hemisphere swelling a large bilateral fronto-temporo-parietal craniectom

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with head injury 2. age 18-65 3. Abnormal CT 4. ICP monitoring 5. refractory ICP to standard treatment for 1-12 hours

Exclusion criteria

Exclusion criteria: Bilateral fixed and dilated pupils, bleeding diathesis, devastating injury not expected to survive for 24 hours, follow up not possible, patients treated on the Lund protocol, have recieved Barbiturates pre-randomisation, significant brain stem involvement on CT

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be assessment of outcome at discharge( Glasgow outcome Score) and 6 months( Extended Goasgow outcome Score)	—

Secondary

Measure	Time frame
Secondary endpoints will be: a. Assessment of outcome using the SF-36 and SF-10( for children below 16 years of age) questionnaires b. Assessment of ICP control c. Time in intensive care d. Time to discharge from neurosurgical unit e. Detailed health-economic analysis	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)