The Tilburg Vasospasm Study

Phase 3TerminatedNCT01407614

Elisabeth-TweeSteden Ziekenhuis20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Brain Ischemia Intracranial Vasospasm

Interventions

external lumbar drainage (ELD) of cerebrospinal fluidPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St Elisabeth Hospital

Tilburg, North Brabant, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Patients will be followed for the duration of admission, an expected average of 3 weeks

Secondary Outcomes

dichotomized Glasgow outcome score (GOS)

Glasgow outcome scale was measured at discharge

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

new ischemic lesions on cerebral CT scan

Time frame: at 3 months after initial bleeding

length of stay in intensive care unit

The length of stay in the intensive care unit will be measured.

Time frame: 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

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.

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

dichotomized Glasgow outcome score (GOS

Time frame: at 3 months after initial bleeding

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.