The Tilburg Vasospasm Study

NCT ID: NCT01407614

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Brain Ischemia; Intracranial Vasospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

external lumbar drainage (ELD) of cerebrospinal fluid

Intervention Type: PROCEDURE

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

In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Neurosurgery St Elisabeth Hospital The Netherlands

Principal Investigators

Paul Depauw, MD

Role: PRINCIPAL_INVESTIGATOR

Elisabeth-TweeSteden Ziekenhuis

Locations

St Elisabeth Hospital

Tilburg, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

15378

Identifier Type: -

Identifier Source: org_study_id