Lumbar Drainage in Subarachnoid Haemorrhage

NCT00842049 | Completed Phase 2 DMC

• 1 other identifier: 06/Q1205/170
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Subarachnoid haemorrhage; Aneurysm; Cerebrospinal fluid drainage

Outcome Measures

Primary Outcomes (1)

• Incidence of delayed ischaemic neurological deficit

  Within 21 days of haemorrhagic ictus

Secondary Outcomes (4)

• Modified Rankin Score

  10 days and 6 months following haemorrhagic ictus

• Incidence of cerebrospinal fluid shunting

  Within 12 months of haemorrhagic ictus

• Incidence of completed infarct secondary to delayed ischaemic neurological deficit

  Within 21 days of ictus

• Incidence of cerebrospinal fluid infection secondary to lumbar drainage

  Within 8 weeks of removal of lumbar drain

Study Arms (2)

Study

EXPERIMENTAL

Insertion of lumbar drain

Device: Lumbar Drain (Medtronic lumbar drainage system)

Control

OTHER

Normal clinical management without lumbar drain

Other: No lumbar drain

Interventions

Lumbar Drain (Medtronic lumbar drainage system) DEVICE

Insertion of lumbar drain to drain cerebrospinal fluid

Also known as: Medtronic lumbar drainage system

Study

No lumbar drain OTHER

No lumbar drain

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aneurysmal subarachnoid haemorrhage.
• Recruitment prior to day three post-haemorrhage.
• Written informed consent or relative assent given.
• WFNS grade 1-3.
• Fisher grade 2, 3 and 4 (without space occupying haematoma) on initial CT scan.
• No intraventricular haemorrhage, space occupying haematoma or other contra-indication to lumbar puncture.

You may not qualify if:

• Non-aneurysmal subarachnoid haemorrhage.
• Delayed presentation / recruitment (after day three post-haemorrhage)
• Written informed consent or relative assent denied or unobtainable.
• WFNS grade 4 or 5.
• Fisher grade 1 on initial CT scan.
• Intraventricular haematoma obstructing ventricular outflow.
• Intracranial haematoma with mass effect.
• Bleeding diathesis.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds General Infirmary

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (2)

• Klimo P Jr, Kestle JR, MacDonald JD, Schmidt RH. Marked reduction of cerebral vasospasm with lumbar drainage of cerebrospinal fluid after subarachnoid hemorrhage. J Neurosurg. 2004 Feb;100(2):215-24. doi: 10.3171/jns.2004.100.2.0215.

  PMID: 15086227 BACKGROUND

• Al-Tamimi YZ, Bhargava D, Feltbower RG, Hall G, Goddard AJ, Quinn AC, Ross SA. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS). Stroke. 2012 Mar;43(3):677-82. doi: 10.1161/STROKEAHA.111.625731. Epub 2012 Jan 26.

  PMID: 22282887 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm; Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Wounds and Injuries

Study Officials

• Yahia Al-Tamimi, MCChB(Hons)

  Leeds Teaching Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Stuart Ross, FRCS(SN)

  Leeds Teaching Hospital NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: November 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

GB (1)