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Lumbar Drainage in Subarachnoid Haemorrhage (LUMAS)

This study has been completed.
Sponsor:
Information provided by:
The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00842049
First received: February 11, 2009
Last updated: February 22, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Subarachnoid Hemorrhage
Device: Lumbar Drain (Medtronic lumbar drainage system)
Other: No lumbar drain
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lumbar Drainage of Cerebrospinal Fluid in Aneurysmal Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Leeds Teaching Hospitals NHS Trust:

Primary Outcome Measures:
  • Incidence of delayed ischaemic neurological deficit [ Time Frame: Within 21 days of haemorrhagic ictus ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Score [ Time Frame: 10 days and 6 months following haemorrhagic ictus ] [ Designated as safety issue: No ]
  • Incidence of cerebrospinal fluid shunting [ Time Frame: Within 12 months of haemorrhagic ictus ] [ Designated as safety issue: No ]
  • Incidence of completed infarct secondary to delayed ischaemic neurological deficit [ Time Frame: Within 21 days of ictus ] [ Designated as safety issue: No ]
  • Incidence of cerebrospinal fluid infection secondary to lumbar drainage [ Time Frame: Within 8 weeks of removal of lumbar drain ] [ Designated as safety issue: Yes ]

Enrollment: 210
Study Start Date: November 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study
Insertion of lumbar drain
Device: Lumbar Drain (Medtronic lumbar drainage system)
Insertion of lumbar drain to drain cerebrospinal fluid
Other Name: Medtronic lumbar drainage system
Control
Normal clinical management without lumbar drain
Other: No lumbar drain
No lumbar drain

Detailed Description:

All patients who present to our department with proven aneurysmal SAH and fit the inclusion criteria (see below) will be approached for inclusion into the trial. Written informed consent will be sought prior to recruitment into the study. Written assent from the patient's relatives will be sought in those cases where neurological impairment prevents written informed consent being obtained from the patient. The patient will subsequently be randomised into the control arm or the study arm of the trial. The control arm consists of normal therapeutic intervention, including external ventricular drainage if required for hydrocephalus. Those randomised to the therapeutic arm will have a lumbar drain inserted and set to drain CSF at 5 ml/hour. This will continue until CSF is no longer blood stained or until day 10 following insertion.

Primary outcome measures:

1. Incidence of delayed ischaemic neurological deficit. This is defined as new neurological deficit and/or impairment of consciousness without other identifiable cause at least three days post haemorrhage.

New impairment of consciousness is defined as a drop in the Glasgow Coma Score of 1 motor point or 2 verbal/eye opening points.

Secondary outcome measures:

  1. Modified Rankin Score at day 10 post ictus and at 6 months.
  2. Severity of delayed neurological deficit and the development of a complete infarct.
  3. Incidence of cerebrospinal fluid infection secondary to lumbar drainage

Special note:

If a patient has presented greater than three days following the initial bleed, any neurological deficit present may be a delayed neurological deficit and thus must be excluded from the trial. Should the lumbar drain fall out prematurely the patient will be asked whether they wish to continue in the study and, if so, the lumbar drain will be reinserted and management will continue as before. Patients showing signs of lumbar drain infection will have the drain removed, a sample of CSF and the drain tip sent to the microbiology laboratory and appropriate antibiotic therapy instituted.

The neurosurgical unit at Leeds General Infirmary treated 313 patients with acute subarachnoid haemorrhage in the three years 1997-2000. Of these 243 patients would have been suitable for this study on the basis of their admission clinical status. The power calculation was derived from the estimate that 40% of patients treated with standard therapy will develop clinical vasospasm. If the retrospective study showed a minimum of 20% improvement in its outcome variables then we expect to see the same improvement. For an 85% power this requires 105 patients in each arm. We expect this to take 3.5 years based on the number of eligible patients that present to our unit with a 60-70% recruitment rate (approximately 30 patients per year per arm).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Non-aneurysmal subarachnoid haemorrhage.
  2. Delayed presentation / recruitment (after day three post-haemorrhage)
  3. Written informed consent or relative assent denied or unobtainable.
  4. WFNS grade 4 or 5.
  5. Fisher grade 1 on initial CT scan.
  6. Intraventricular haematoma obstructing ventricular outflow.
  7. Intracranial haematoma with mass effect.
  8. Bleeding diathesis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842049

Locations
United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
Investigators
Principal Investigator: Yahia Al-Tamimi, MCChB(Hons) Leeds Teaching Hospital NHS Trust
Study Director: Stuart Ross, FRCS(SN) Leeds Teaching Hospital NHS Trust
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr Yahia Al-Tamimi, Leeds Teaching Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00842049     History of Changes
Other Study ID Numbers: 06/Q1205/170
Study First Received: February 11, 2009
Last Updated: February 22, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by The Leeds Teaching Hospitals NHS Trust:
Subarachnoid haemorrhage
Aneurysm
Cerebrospinal fluid drainage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014