Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336466
Status:
COMPLETED
Last Update Posted:
2007-11-27
First Post:
2006-06-12
Brief Title:
The Erythropoietin NeuroProtective Effect Assessment in CABG Surgery TENPEAKS
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Erythropoietin NeuroProtective Effect Assessment in CABG Surgery TENPEAKS A Randomized Double-Blind Placebo Controlled Proof-of-Concept Clinical Trial
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Context Neurocognitive dysfunction complicates coronary artery bypass graft surgery Neurocognitive dysfunction is a measurable problem with thinking Erythropoietin may be a neuroprotectant
Objective To investigate the feasibility and safety of three doses of human recombinant erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients
Objective To investigate the feasibility and safety of three doses of human recombinant erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients
Detailed Description:
Coronary artery bypass surgery CABG is performed each year on over 500000 patients in the US and almost 30000 patients in Canada to treat coronary artery disease However it is complicated by a significant postoperative risk of neurologic sequelae including stroke and neurocognitive dysfunction NCD Clinically overt stroke which may be seen in 1-4 of patients is far less common than NCD which is reported in approximately 50-75 of patients at discharge 20-50 at 6 weeks and up to 40 at five yearsHuman recombinant erythropoietin rh-Epo is not only approved in this population for prophylactic use to reduce blood transfusions but has become an agent of intense interest for neuroprotection as a result of in vitro data animal experiments and now two promising preliminary trials in human patients There are not however any pilot data by which to estimate an appropriate dose or treatment effect of rh-Epo on NCD specifically It is imperative both to refine estimates of control group incidence rates treatment effect and test variability in CABG as well to demonstrate the feasibility and safety of a study protocol prior to embarking on a larger randomized controlled trial powered with an adequate sample size to investigate the efficacy of rh-Epo in the reduction of peri-operative NCD We propose a six month prospective study in CABG patients to investigate the feasibility and safety of three prophylactic doses of human recombinant erythropoietin rh-Epo in a randomized placebo controlled study The four study arms are placebo 375 Ukg 750 Ukg or 1500 Ukg of human recombinant erythropoietin intravenously divided in three doses the day before the day of and the day after surgery The primary outcomes of this pilot will be study feasibility and patient safety as measured by ICU and Hospital length of stay 28 day all cause mortality and incidence of morbidity including pure red cell aplasia PRCA stroke myocardial infarction re-operation deep vein thrombosis and pulmonary thromboembolism The secondary outcome will be the incidence of neurocognitive dysfunction among the four study arms and between placebo and rh-Epo at any dose As well little is known about the pharmacology of rh-Epo in crossing the blood-brain barrier In those patients receiving a spinal anesthetic in addition to a general anesthetic as part of their normal care CSF will be analyzed for rh-Epo concentration and then compared to drug dose and serum level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None