Erythropoietin Therapy for Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Roche Foundation of Anemia Research (RoFAR, Switzerland)
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00140010
First received: August 29, 2005
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

ABSTRACT:

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.

PURPOSE:

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.


Condition Intervention Phase
Aneurysmal Subarachnoid Hemorrhage
Drug: erythropoietin beta
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • cerebral vasospasm indices (incidence, onset, severity) on transcranial Doppler [ Time Frame: 14 days following aneurysmal subarachnoid hemorrhage ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: April 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>= 18 years)
  • Aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

  • Uncontrolled systemic hypertension (systolic blood pressure > 220 mmHg)
  • Erythrocytosis vera
  • Concurrent erythropoietin therapy
  • Negative angiography
  • Subarachnoid hemorrhage more than 7 days
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140010

Locations
United Kingdom
Department of Neurosurgery, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Sponsors and Collaborators
University of Cambridge
Hoffmann-La Roche
Roche Foundation of Anemia Research (RoFAR, Switzerland)
Investigators
Principal Investigator: Peter J Kirkpatrick, FRCS(SN) University of Cambridge
  More Information

Publications:
Responsible Party: Ming-Yuan Tseng, University of Cambridge
ClinicalTrials.gov Identifier: NCT00140010     History of Changes
Other Study ID Numbers: 04/Q0108/87, 2004-001141-15
Study First Received: August 29, 2005
Last Updated: May 19, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Cambridge:
aneurysm
autoregulation
erythropoietion
stroke
subarachnoid hemorrhage
vasospasm

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014