The Tilburg Vasospasm Study

This study has been terminated.
(patient enrollment too slow)
Sponsor:
Information provided by:
St. Elisabeth Hospital, Tilburg, Netherlands
ClinicalTrials.gov Identifier:
NCT01407614
First received: January 10, 2011
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage.


Condition Intervention Phase
Brain Ischemia
Intracranial Vasospasm
Procedure: external lumbar drainage (ELD) of cerebrospinal fluid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Elisabeth Hospital, Tilburg, Netherlands:

Primary Outcome Measures:
  • Clinical signs of delayed cerebral ischemia [ Time Frame: Patients will be followed for the duration of admission, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    DCI was diagnosed when all of the following criteria were met: (1) the onset of new neurological deficits such as confusion, disorientation, drowsiness, or focal deficit during post-hemorrhage days (4 to 14); (2) negative findings on CT obtained to rule out other causes of neurological deterioration such as hemorrhage, cerebral edema, or hydrocephalus. (3) No other identifiable cause of neurological deterioration such as hyponatriemia, hypoxia, drug toxicity, infection, or seizures.


Secondary Outcome Measures:
  • dichotomized Glasgow outcome score (GOS) [ Time Frame: at discharge, an expected average of 3 weeks after initial bleeding ] [ Designated as safety issue: No ]
    Glasgow outcome scale was measured at discharge

  • new ischemic lesions on cerebral CT scan [ Time Frame: at 3 months after initial bleeding ] [ Designated as safety issue: No ]
  • length of stay in intensive care unit [ Time Frame: Patients will be followed from initial admission until discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    The length of stay in the intensive care unit will be measured.

  • rebleeding rate of unsecured aneurysms and complications of external lumbar drainage [ Time Frame: Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days ] [ Designated as safety issue: Yes ]
    Evaluation of rebleeding rate of unsecured cerebral aneurysms during external lumbar drainage (ELD) of cerebrospinal fluid and evaluation of (other) complications of ELD such as (local)infection, discomfort/pain.

  • dichotomized Glasgow outcome score (GOS [ Time Frame: at 3 months after initial bleeding ] [ Designated as safety issue: No ]
  • clinical signs of delayed cerebral ischemia [ Time Frame: At 3 months after initial bleeding ] [ Designated as safety issue: No ]
    As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.


Enrollment: 20
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: external lumbar drainage
Within 96 hours of initial subarachnoid hemorrhage, patients were randomized for external lumbar drainage (ELD)of cerebrospinal fluid during a maximum of 7 days or standard treatment of subarachnoid hemorrhage without ELD
Procedure: external lumbar drainage (ELD) of cerebrospinal fluid
Patients were randomized for external lumbar drainage of cerebrospinal fluid or standard treatment of a subarachnoid hemorrhage alone. External drainage was started within 96 hours of initial subarachnoid hemorrhage during 7 days at a maximum of 5-10 ml/hour.
No Intervention: No intervention
In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage

Detailed Description:

Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.

We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.

  Eligibility

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

Inclusion Criteria:

  • spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
  • CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
  • the drainage can start prior to the treatment of the ruptured aneurysm
  • informed consent is signed by the patient or his representative

Exclusion Criteria:

  • spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
  • traumatic SAH
  • symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
  • the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
  • the presence of a mass lesion with significant cerebral midline shift
  • all patients whose neurological condition is too poor to allow clinical recognition of signs and symptoms of cerebral vasospasm. This includes all patients with a Hunt and Hess Grade V who failed to improve after initial resuscitation
  • no informed consent
  • mycotic aneurysms
  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: NCT01407614

Locations
Netherlands
St Elisabeth Hospital
Tilburg, Brabant, Netherlands, 5022 GC
Sponsors and Collaborators
St. Elisabeth Hospital, Tilburg, Netherlands
Investigators
Principal Investigator: Paul Depauw, MD St. Elisabeth Hospital, Tilburg, Netherlands
  More Information

No publications provided

Responsible Party: P.R.A.M. Depauw / drs, Neurosurgery St Elisabeth Hospital The Netherlands
ClinicalTrials.gov Identifier: NCT01407614     History of Changes
Other Study ID Numbers: 15378
Study First Received: January 10, 2011
Last Updated: August 1, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by St. Elisabeth Hospital, Tilburg, Netherlands:
Subarachnoid hemorrhage
delayed cerebral ischemia
external lumbar drainage
vasospasm

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

ClinicalTrials.gov processed this record on October 19, 2014