Erythropoietin Therapy for Subarachnoid Hemorrhage
Delayed ischemic deficits (DID) and strokes caused by low cerebral blood flow (CBF) are major sources of poor outcome following aneurysmal subarachnoid hemorrhage (SAH). DID are often accompanied by vasospasm and abnormalities in cerebrovascular autoregulation, an important reflex involved in the defense against low CBF. Assessment of vasospasm and impaired autoregulation can be conveniently measured non-invasively by use of transcranial Doppler (TCD) and the transient hyperaemic response test (THRT). Vasospasm and abnormalities in the THRT can predict those patients who are at risk of developing DID. In this study, the investigators wish to explore the neuroprotective and angiogenic effects of systemic erythropoietin (EPO) therapy on vasospasm and autoregulation following SAH, and examine whether any improvements translate into reduced incidences of DID and poor outcome. Eighty patients with SAH will be recruited over one year to receive three doses in the first week of either intravenous epoetin beta 30000 IU or placebo (0.9% saline) 50 ml/30 min as part of a randomized, double-blind, placebo-controlled trial. The investigators propose daily TCD assessment for detecting vasospasm and abnormal autoregulation. Outcome measures will examine the influence of EPO therapy on the incidence, severity, and duration of vasospasm, abnormal autoregulation, and DID.
This study is a randomized, double-blind, placebo-controlled clinical trial investigating the potentially beneficial effects of systemic recombinant human erythropoietin therapy (Epoetin beta, NeoRecormon®, Roche, 30000IU/50 ml/30 min, three times in the first week) on cerebral autoregulation and incidence of delayed ischemic deficits (DID) following aneurysmal subarachnoid haemorrhage (SAH).
HYPOTHESIS Systemic recombinant human erythropoietin therapy can be used safely following SAH to ameliorate vasospasm, improve cerebral autoregulation, reduce DID, and facilitate neurological recovery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Systemic Erythropoietin Therapy on Cerebral Autoregulation and Incidence of Delayed Ischemic Deficits in Patients With Aneurysmal Subarachnoid Hemorrhage|
- cerebral vasospasm indices (incidence, onset, severity) on transcranial Doppler [ Time Frame: 14 days following aneurysmal subarachnoid hemorrhage ] [ Designated as safety issue: Yes ]
- delayed ischemic neurological deficits [ Time Frame: 14 days following aneurysmal subarachnoid haemorrhage ] [ Designated as safety issue: Yes ]
- disability measured with modified Rankin Scale, Glasgow Outcome Scale, National Institute of Stroke Scale [ Time Frame: 6 months following aneurysmal subarachnoid haemorrhage ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
30,000 units of erythropoietin beta in one vial; 3 vials as one set per patient
Drug: erythropoietin beta
30,000 units in 6 mL of 0.9% saline IV for 15 minutes every other day for 3 doses within 72 hours after aneurysmal subarachnoid hemorrhage
Other Name: erythropoietin, epoetin
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|Department of Neurosurgery, Addenbrooke's Hospital|
|Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ|
|Principal Investigator:||Peter J Kirkpatrick, FRCS(SN)||University of Cambridge|