Prospective, Randomized Trial of Higher Goal Hemoglobin After SAH
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Status:
Ongoing. The study is currently recruiting patients, and as of June 24, 2008, 34 patients have been randomized into the study.
Purpose:
To assess the safety and feasibility of a goal hemoglobin (hgb) 11.5 g/dL vs. 10 g/dL after aneurysmal subarachnoid hemorrhage (SAH).
Year Started:
2006
Design:
Prospective, randomized, pilot study.
Inclusion Criteria
Patients with WFNS grade I SAH who have thick clot (Columbia SAH CT Scores 3-4), WFNS grades 2-4 (after placement of a ventricular drain), randomization within 3 days of hemorrhage, and aneurysm obliteration feasible/imminent.
Patient Involvement:
Patients will be randomly assigned to a goal hemoglobin of at least 10 g/dL or 11.5 g/dL from time of enrollment through 14 days after hemorrhage or hospital discharge, whichever is first.
Primary Outcome:
Safety and adverse events: ventilator free days, new fever, transaminases > 2 times ULN, pulmonary edema, congestive heart failure, transfusion reaction or blood borne diseases.
Secondary Outcome:
Discharge/14 day NIH Stroke Scale and modified Rankin Scale (mRS), cerebral infarction on MRI (B1000), and 28-day and 3 month mRS.
Source of Information:
Correspondence with trial coordinator.
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This information last updated on: 9/29/2009
Reviewed on: 09/28/2009.
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