The Tilburg Vasospasm Study

Elisabeth-TweeSteden Ziekenhuis

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Brain Ischemia; Intracranial Vasospasm

Treatments: Procedure: external lumbar drainage (ELD) of cerebrospinal fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT01407614

15378

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

external lumbar drainage

Active Comparator group

Description:

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

Treatment:

Procedure: external lumbar drainage (ELD) of cerebrospinal fluid

No intervention

No Intervention group

Description:

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