STITCH (Trauma): Early Surgery for Traumatic Intracerebral Hemorrhage (2014)

“This trial has not shown a benefit from a policy of early surgery for traumatic intracerebral hemorrhage. The confidence intervals are wide and do not exclude a modest but clinically important benefit or harm from early surgery.”

— The STITCH (Trauma) Investigators

1. Publication Details

  • Trial Title: Early surgery versus initial conservative treatment in patients with traumatic intracerebral hemorrhage (STITCH[Trauma]): the first randomized trial.
  • Citation: Mendelow AD, Gregson BA, Gholkar A, et al; for the STITCH(Trauma) Investigators. Early surgery versus initial conservative treatment in patients with traumatic intracerebral hemorrhage (STITCH[Trauma]): the first randomized trial. Lancet Neurol. 2014;13(7):659-667. doi:10.1016/S1474-4422(14)70103-3.
  • Published: July 1, 2014, in The Lancet Neurology.
  • Author: A. David Mendelow, D.Sc., F.R.C.S.
  • Funding: UK Medical Research Council and The Stroke Association.

2. Keywords

Traumatic Brain Injury (TBI), Traumatic Intracerebral Hemorrhage (TICH), Neurosurgery, Craniotomy, Glasgow Coma Scale (GCS), Neurocritical Care.

3. The Clinical Question

In adult patients with a traumatic intracerebral hemorrhage (TICH) (Population), does a policy of early surgical hematoma evacuation (Intervention) compared to a policy of initial conservative treatment (Comparison) improve functional outcome at 6 months (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Traumatic intracerebral hemorrhage (TICH) is a common and serious consequence of head injury. While surgery is often performed for large hematomas causing significant mass effect, the role and timing of surgery for other TICHs were unclear.
  • Knowledge Gap: There were no randomized controlled trials to guide the use of early surgery for TICH. The decision to operate was based on surgeon preference and observational data, with significant practice variation worldwide. It was unknown if a policy of early evacuation improved outcomes.
  • Proposed Hypothesis: The authors hypothesized that a policy of early surgery would improve functional outcomes at 6 months compared to a policy of initial conservative treatment for patients with TICH.

5. Study Design and Methods

  • Design: A prospective, multicenter, international, randomized, parallel-group, pragmatic trial. The trial was stopped early due to funding and recruitment issues.
  • Setting: 31 centers in 13 countries.
  • Trial Period: Enrollment from November 2006 to August 2012.
  • Population:
    • Inclusion Criteria: Adult patients (≥14 years) with a primary TICH of at least 10 mL on CT scan, within 48 hours of injury. Patients had to be in equipoise for the treating neurosurgeon regarding the benefit of early surgery.
    • Exclusion Criteria: Extradural or subdural hematomas requiring surgery, severe comorbidities, or pregnancy.
  • Intervention: Early surgical hematoma evacuation within 12 hours of randomization, plus best medical treatment.
  • Control: Initial conservative treatment (best medical treatment), with surgery reserved for neurological deterioration.
  • Management Common to Both Groups: All patients received best medical treatment for traumatic brain injury according to local guidelines.
  • Power and Sample Size: The trial was initially planned to recruit 840 patients but was stopped early after enrolling 170 patients due to the expiration of funding.
  • Outcomes:
    • Primary Outcome: A prognosis-based dichotomized outcome (favorable vs. unfavorable) based on the Extended Glasgow Outcome Scale (GOSE) at 6 months.
    • Secondary Outcomes: Included 6-month mortality and distribution of GOSE scores.

6. Key Results

  • Enrollment and Baseline: 170 patients were randomized (82 to early surgery, 88 to initial conservative treatment). The groups were reasonably well-matched at baseline.
  • Trial Status: The trial was stopped early due to funding constraints and slow recruitment.
  • Primary Outcome: There was no significant difference in the rate of unfavorable outcome at 6 months between the early surgery and initial conservative treatment groups (62% vs 61%; P=0.89).
  • Secondary Outcomes: There was no significant difference in 6-month mortality between the groups (33% vs 34%; P=0.95).
  • Adverse Events: The rates of adverse events were similar between the two groups.

7. Medical Statistics

  • Analysis Principle: An intention-to-treat analysis was performed.
  • Statistical Tests Used: The primary outcome was analyzed using logistic regression.
  • Primary Outcome Analysis: The proportion of patients with a favorable or unfavorable outcome (based on a prognostic model) was compared between the two groups.
  • Key Statistic(s) Reported: Odds Ratio (OR) for unfavorable outcome with early surgery: 1.07 (95% CI, 0.57 to 2.01; P=0.84).
  • Interpretation of Key Statistic(s):
    • Odds Ratio (OR): An OR of 1.07 suggests a slight (7%) but non-significant increase in the odds of an unfavorable outcome with surgery.
    • Confidence Interval (CI): The 95% CI is very wide and crosses 1.0, indicating a high degree of uncertainty and no statistically significant difference.
    • P-value: The p-value of 0.84 confirms the lack of a statistically significant difference.
  • Clinical Impact Measures: Not applicable as no benefit was shown.
  • Subgroup Analyses: A post-hoc analysis suggested a potential benefit for early surgery in the subgroup of patients with a GCS of 9-12, but this was not pre-specified and should be interpreted with caution.

8. Strengths of the Study

  • Study Design and Conduct: This was the first-ever randomized controlled trial to address the role of early surgery for TICH, tackling a major evidence gap in neurotrauma.
  • Pragmatic Design: The trial’s pragmatic approach, including patients for whom surgeons were in equipoise, reflects real-world clinical decision-making.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The trial was severely underpowered because it was stopped early after recruiting only 20% of its target sample size. The wide confidence intervals mean the results are very imprecise. The study was also unblinded.
  • External Validity (Generalizability): The small sample size and early termination severely limit the generalizability of the findings.
  • Other: A significant number of patients (37%) in the conservative treatment group crossed over to receive surgery, which further complicates the interpretation of the results.

10. Conclusion of the Authors

“This trial has not shown a benefit from a policy of early surgery for traumatic intracerebral hemorrhage. The confidence intervals are wide and do not exclude a modest but clinically important benefit or harm from early surgery. A larger trial is needed to provide a definitive answer.”

11. To Summarize

  • Impact on Current Practice: Due to its early termination and lack of statistical power, the STITCH (Trauma) trial did not change clinical practice. It highlighted the significant challenges of conducting surgical trials in neurotrauma. Its main contribution was to underscore the ongoing clinical equipoise and the urgent need for a larger, definitive trial.
  • Specific Recommendations:
    • Patient Selection: For adult patients with traumatic intracerebral hemorrhage.
    • Actionable Intervention: This trial provides no evidence to support a routine policy of early surgery. The decision to operate remains based on clinical judgment, considering factors like hematoma size, mass effect, and the patient’s neurological status.
    • Expected Benefit: No benefit was demonstrated.
  • What This Trial Does NOT Mean: This trial does not mean that surgery is ineffective for TICH. It was too small to draw any firm conclusions, either positive or negative.
  • Implementation Caveats: The management of TICH remains a complex decision guided by clinical assessment and institutional protocols rather than high-level evidence from this trial.

12. Context and Related Studies

  • Building on Previous Evidence: This trial was the traumatic brain injury counterpart to the STICH (2005) and STICH II (2013) trials, which studied spontaneous intracerebral hemorrhage. It attempted to apply a similar rigorous methodology to the field of neurotrauma.
  • Influence on Subsequent Research: The challenges faced by STITCH (Trauma) have informed the design of subsequent neurotrauma trials. The need for a large, definitive trial on this topic remains.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: The central question of whether early surgery benefits patients with TICH remains unanswered. The optimal timing and technique (craniotomy vs. minimally invasive) are also unknown.
  • Future Directions: A large, adequately powered randomized controlled trial is still needed to definitively determine the role of early surgery in the management of traumatic intracerebral hemorrhage.

14. External Links

15. Framework for Critical Appraisal

  • Clinical Question: The question was highly relevant and addressed a common and important clinical problem in neurotrauma with no existing RCT evidence.
  • Methods: The multicenter RCT design was appropriate. However, the study’s premature termination is a fatal flaw in terms of its ability to provide a reliable answer.
  • Results: The trial was severely underpowered, and therefore, the neutral result is inconclusive. The wide confidence intervals mean that a clinically important benefit or harm cannot be ruled out.
  • Conclusions and Applicability: The authors’ conclusion is appropriately cautious and is the only conclusion that can be drawn from the available data. The trial is not applicable for guiding clinical practice, but it serves as an important lesson in the challenges of conducting surgical trials and a justification for future, better-funded research.

16. Disclaimer and Contact

This summary is provided by the Academic Committee of ESBICM (ACE) to facilitate the understanding of this study; readers are advised to refer to the original trial document for a deeper understanding. If you find any information incorrect, or missing, or it needs an update or have a request for a specific critical care trial summary, kindly write to us at academics[at]esbicm.org.

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