Clinical Trial: The Tilburg Vasospasm Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Elisabeth-TweeSteden Ziekenhuis

Current Primary Outcome: Clinical signs of delayed cerebral ischemia [ Time Frame: Patients will be followed for the duration of admission, an expected average of 3 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • dichotomized Glasgow outcome score (GOS) [ Time Frame: at discharge, an expected average of 3 weeks after initial bleeding ]
    Glasgow outcome scale was measured at discharge
  • new ischemic lesions on cerebral CT scan [ Time Frame: at 3 months after initial bleeding ]
  • length of stay in intensive care unit [ Time Frame: Patients will be followed from initial admission until discharge, an expected average of 3 weeks ]
    The length of stay in the intensive care unit will be measured.
  • rebleeding rate of unsecured aneurysms and complications of external lumbar drainage [ Time Frame: Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days ]
    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.
  • dichotomized Glasgow outcome score (GOS [ Time Frame: at 3 months after initial bleeding ]
  • clinical signs of delayed cerebral ischemia [ Time Frame: At 3 months after initial bleeding ]
    As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.


Original Secondary Outcome: Same as current

Information By: Elisabeth-TweeSteden Ziekenhuis

Dates:
Date Received: January 10, 2011
Date Started: December 2007
Date Completion:
Last Updated: August 1, 2011
Last Verified: August 2011