Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA (OPHELIE)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA|
- OPHELIE [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The proportion of the patients with modified Rankin Scale 0-1
- OPHELIE [ Time Frame: 7 days ] [ Designated as safety issue: No ]The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition
|Study Start Date:||November 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
High sc-tPA/tc-tPA ratio group
A threshold value of the sc-tPA/tc-tPA ratio will be defined as the median value found in the population. The High sc-tPA/tc-tPA ratio group will be defined as the group of patients with a sc-tPA/tc-tPA ratio higher than the median
Low sc-tPA/tc-tPA ratio
A threshold value of the sc-tPA/tc-tPA ratio will be defined as the median value found in the population. The Low sc-tPA/tc-tPA ratio group will be defined as the group of patients with a sc-tPA/tc-tPA ratio lower than the median
OPHELIE is a multicenter study conducted in France in 25 centers where patients treated by iv rt-PA will be included. Patients are treated according to the local protocol, without any modification specifically for this study. A sample of 2 drops of the rt-PA used for the treatment is stored for analysis, to determine the sc-tPA/tc-tPA ration (immunostaining).
700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified Rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%.
The participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. Assuming that 70% will be eligible, the recruitment should take less than 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614080
|Lille University Hospital|
|Lille, France, 59037|
|Study Director:||Kei MURAO, MD||University Lille 2|
|Study Chair:||Denis VIVIEN, PhD||Institut National de la Santé Et de la Recherche Médicale, France|
|Principal Investigator:||Didier LEYS, MD, PhD||Lille University Hospital|