Surgical Trial In Traumatic intraCerebral Haemorrhage

Completed

• Conditions: Injury, Occupational Diseases, Poisoning; Intracerebral haemorrhage; Traumatic intracerebral haemorrhage and contusion

• Registration Number: ISRCTN19321911
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1. Both males and females, adults aged 14 or over
2. Evidence of a traumatic intracerebral haemorrhage (TICH) on computed tomography (CT) with a single volume of attenuation significantly raised above that of the background white and grey matter that is in total greater than 10 ml calculated by width times height times length in cm divided by 2
3. Within 24 hours of head injury
4. Clinical equipoise: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible

Exclusion Criteria

1. A significant surface haematoma (epidural haematoma [EDH] or subdural haematoma [SDH]) requiring surgery (The indications for intervention for these patients are already very well defined)
2. More than two separate haematomas fulfilling inclusion criteria
3. If surgery can not be performed within 36 hours of injury or 12 hours of randomisation (whichever is the shorter)
4. Severe pre-existing physical or mental disability or severe co-morbidity which might lead to a poor outcome even if the patient made a full recovery from the head injury (Examples would be a high level of dependence before the injury or severe irreversible associated injury such as complete spinal cord injury)
5. Permanent residence outside a study country preventing follow up
6. Patient and/or relative has a strong preference for one treatment modality

Study & Design

• Study Type: Interventional
• Study Design: Not specified