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Lumbar Drainage in Subarachnoid Haemorrhage

NCT00842049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-12-22

No results posted yet for this study

Summary

Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). Despite modern medicine, the death and disability rate remains high both from the initial bleed and from the associated complications such as vasospasm. This is characterised by neurological impairment seen following the bleed. Despite modern treatment this is still associated with a poor outcome. This has significant implications due to the long term intensive neuro-rehabilitation these patients will require.

A recent study has shown that placing a small drain in the lower back following a subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better outcome. This trial was not optimally performed and so a trial is needed to look at this in more detail. The investigators have set up such a trial in our neurosurgical unit. If the investigators confirm that there is an improvement in patient outcome, it will change our practice in the future.

Conditions

  • Subarachnoid Hemorrhage

Interventions

DEVICE

Lumbar Drain (Medtronic lumbar drainage system)

Insertion of lumbar drain to drain cerebrospinal fluid

OTHER

No lumbar drain

No lumbar drain

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Yahia Al-Tamimi, MCChB(Hons) · Leeds Teaching Hospital NHS Trust

  • Stuart Ross, FRCS(SN) · Leeds Teaching Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842049 on ClinicalTrials.gov