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The erythropoietin neuroprotective effect: assessment in CABG surgery (TENPEAKS). A randomized, double-blind, placebo controlled, proof-of-concept clinical trial
Stroke, 06/29/09

Haljan G et al. – Findings show feasibility and safety for use of human recombinant erythropoietin as a neuroprotectant in coronary artery bypass graft surgery. A trend in reduction of neurocognitive dysfunction at 2 mo was associated with erythropoietin use.

• Study of whether human recombinant erythropoietin reduces the incidence of neurocognitive dysfunction after surgery
• Randomization of 32 elective first-time coronary artery bypass graft pts to placebo or recombinant human erythropoietin, starting the day before surgery
• Recombinant human erythropoietin: 375 U/kg, 750 U/kg, or 1500 U/kg divided in 3 daily doses
• Primary outcomes: feasibility and safety
• Secondary outcomes: neurocognitive dysfunction at discharge and 2 mo
• Subjects: male, mean age 60 yrs (range 46-73)

• No significant differences in pump time, cross-clamp time, or hospital stay
• No mortality or pure red cell aplasia
• ST changes compatible with myocardial injury immediately postoperatively in 1 pt in 375 U/kg
• No other thrombotic complications
• Neurocognitive dysfunction in 21/32 (66%) of pts at discharge and 5/32 (16%) at 2 mo
• Neurocognitive dysfunction at discharge: placebo 6/8 (75%), 375 U/kg 4/8 (50%), 750 U/kg 6/8 (75%), and 1500 U/kg 5/8 (63%)
• Neurocognitive dysfunction at 2 mo: placebo 3/8 (38%), 375 U/kg 1/8 (13%), 750 U/kg 1/8 (13%), and 1500 U/kg 0/8 (0%)
• Neurocognitive dysfunction at 2 mo for erythropoietin at any dose was 2/24 (8.3%) vs 3/8 (38%) for placebo

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