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Open Access Highly Accessed Study protocol

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

Barbara A Gregson1, Elise N Rowan1*, Patrick M Mitchell1, Andy Unterberg2, Elaine M McColl3, Iain R Chambers4, Paul McNamee5 and A David Mendelow1

Author Affiliations

1 Neurosurgical Trials Unit, 3–4 Claremont Terrace, Newcastle University, Newcastle upon Tyne, NE2 4AE, UK

2 Department of Neurosurgery, University of Heidelberg, Im Neuenheimer Feld 400, Heidelberg, D-69120, Germany

3 Institute of Health and Society, Newcastle CTU, 4th Floor, William Leech Building, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK

4 James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK

5 Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Forester Hill Aberdeen, Scotland, AB25 2ZD, UK

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Trials 2012, 13:193  doi:10.1186/1745-6215-13-193

Published: 16 October 2012

Abstract

Background

Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH.

Methods/Design

The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial.

Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise.

Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury.

Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients.

Trial registration

Current Controlled Trials ISRCTN19321911

Keywords:
Head injury; Traumatic intracerebral hemorrhage; Hematoma; Early surgery