The Tilburg Vasospasm Study - Full Text View

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

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

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:

Brain Ischemia
Ischemia
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Hemorrhage

ClinicalTrials.gov processed this record on May 21, 2013