The Tilburg Vasospasm Study

NCT01407614 | Terminated Phase 2 DMC

• 1 other identifier: 15378
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Ischemia; Intracranial Vasospasm

Keywords

Subarachnoid hemorrhage; delayed cerebral ischemia; external lumbar drainage; vasospasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• dichotomized Glasgow outcome score (GOS)

  at discharge, an expected average of 3 weeks after initial bleeding

• new ischemic lesions on cerebral CT scan

  at 3 months after initial bleeding

• length of stay in intensive care unit

  Patients will be followed from initial admission until discharge, an expected average of 3 weeks

• rebleeding rate of unsecured aneurysms and complications of external lumbar drainage

  Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days

• dichotomized Glasgow outcome score (GOS

  at 3 months after initial bleeding

Study Arms (2)

external lumbar drainage

ACTIVE COMPARATOR

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

No intervention

NO INTERVENTION

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

Interventions

external lumbar drainage (ELD) of cerebrospinal fluid 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.

external lumbar drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elisabeth-TweeSteden Ziekenhuis: lead

Study Sites (1)

St Elisabeth Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

Location

MeSH Terms

Conditions

Brain Ischemia; Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Depauw, MD

  Elisabeth-TweeSteden Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: August 2, 2011
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 2, 2011

Record last verified: 2011-08

Locations

NL (1)