The Tilburg Vasospasm Study

Brain Ischemia Clinical Trial

Official title:

Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01407614
• Other study ID #: 15378
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 10, 2011
• Last updated: August 1, 2011
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2011
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Ischemia
• Intracranial Vasospasm
• Ischemia
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

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.

Locations

Country	Name	City	State
Netherlands	St Elisabeth Hospital	Tilburg	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical signs of delayed cerebral ischemia	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.	Patients will be followed for the duration of admission, an expected average of 3 weeks	No
Secondary	dichotomized Glasgow outcome score (GOS)	Glasgow outcome scale was measured at discharge	at discharge, an expected average of 3 weeks after initial bleeding	No
Secondary	new ischemic lesions on cerebral CT scan		at 3 months after initial bleeding	No
Secondary	length of stay in intensive care unit	The length of stay in the intensive care unit will be measured.	Patients will be followed from initial admission until discharge, an expected average of 3 weeks	No
Secondary	rebleeding rate of unsecured aneurysms and complications of external lumbar drainage	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.	Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days	Yes
Secondary	dichotomized Glasgow outcome score (GOS		at 3 months after initial bleeding	No
Secondary	clinical signs of delayed cerebral ischemia	As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.	At 3 months after initial bleeding	No