Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma))

study protocol for a randomized controlled trial

Barbara A. Gregson, Elise N. Rowan*, Patrick M. Mitchell, Andy Unterberg, Elaine M. McColl, Iain R. Chambers, Paul McNamee, A. D. Mendelow

*Corresponding author for this work

Research output: Contribution to journalArticle

21 Citations (Scopus)
4 Downloads (Pure)

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.

Original languageEnglish
Article number193
JournalTrials
Volume13
DOIs
Publication statusPublished - 16 Oct 2012

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Traumatic Cerebral Hemorrhage
Randomized Controlled Trials
Wounds and Injuries
Craniocerebral Trauma
Hematoma
Intracranial Hemorrhages
Contusions
National Institutes of Health (U.S.)
Brain Injuries
Cerebellum

Keywords

  • Early surgery
  • Head injury
  • Hematoma
  • Traumatic intracerebral hemorrhage

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Gregson, B. A., Rowan, E. N., Mitchell, P. M., Unterberg, A., McColl, E. M., Chambers, I. R., ... Mendelow, A. D. (2012). Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial. Trials, 13, [193]. https://doi.org/10.1186/1745-6215-13-193

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)) : study protocol for a randomized controlled trial. / Gregson, Barbara A.; Rowan, Elise N.; Mitchell, Patrick M.; Unterberg, Andy; McColl, Elaine M.; Chambers, Iain R.; McNamee, Paul; Mendelow, A. D.

In: Trials, Vol. 13, 193, 16.10.2012.

Research output: Contribution to journalArticle

Gregson, BA, Rowan, EN, Mitchell, PM, Unterberg, A, McColl, EM, Chambers, IR, McNamee, P & Mendelow, AD 2012, 'Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial', Trials, vol. 13, 193. https://doi.org/10.1186/1745-6215-13-193
Gregson, Barbara A. ; Rowan, Elise N. ; Mitchell, Patrick M. ; Unterberg, Andy ; McColl, Elaine M. ; Chambers, Iain R. ; McNamee, Paul ; Mendelow, A. D. / Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)) : study protocol for a randomized controlled trial. In: Trials. 2012 ; Vol. 13.
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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.",
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AU - Unterberg, Andy

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AB - 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.

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