EARLYDRAIN: outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial
2011

EARLYDRAIN: Study Protocol for Early Lumbar CSF Drainage in Aneurysmal Subarachnoid Hemorrhage

Sample size: 300 publication Evidence: moderate

Author Information

Author(s): Jürgen Bardutzky, Jens Witsch, Eric Jüttler, Stefan Schwab, Peter Vajkoczy, Stefan Wolf

Primary Institution: Charité Center for Stroke Research Berlin

Hypothesis

Early application of a lumbar drain after aneurysmal SAH leads to an improved outcome at six months after the hemorrhage.

Conclusion

The EARLYDRAIN study aims to determine if early lumbar drainage improves clinical outcomes in patients with aneurysmal subarachnoid hemorrhage.

Supporting Evidence

  • Retrospective studies suggest lumbar drainage may reduce the incidence of delayed cerebral ischemia.
  • Previous studies indicated a lower mortality rate in patients receiving lumbar drainage.
  • The study design follows ethical guidelines and has received ethical approval.

Takeaway

This study is trying to find out if putting a drain in the back of patients with a certain type of brain bleed can help them get better after six months.

Methodology

A 2-arm randomized controlled trial comparing early continuous lumbar CSF drainage plus standard care to standard care alone.

Potential Biases

Potential biases may arise from the subjective assessment of outcomes and the variability in treatment protocols across centers.

Limitations

The study may face challenges in recruitment and adherence to the protocol due to the critical condition of patients.

Participant Demographics

Adults aged 18 and older with a first aneurysmal subarachnoid hemorrhage.

Digital Object Identifier (DOI)

10.1186/1745-6215-12-203

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