Monday, March 16, 2020 8:32:00 PM
This observational/retrospective study was completed at the end of 2019 and what was odd was that this was first posted today on clinicaltrials.gov. First time I have seen a completed study posted after the fact.
It is a different study than the REMOVE trial (Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis (NCT03266302) which was a full blown Interventional study. Both studies had a 250 patient enrollment although the REMOVE trial over-enrolled by 38 additional patients bringing it to 288. The data readout in the next several months of the REMOVE study will be the big 'needle mover' assuming that the results are positive and statistically significant.
ClinicalTrials.gov Identifier: NCT04309591
Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis
Actual Study Start Date : October 18, 2019
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : December 4, 2019
It is a different study than the REMOVE trial (Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis (NCT03266302) which was a full blown Interventional study. Both studies had a 250 patient enrollment although the REMOVE trial over-enrolled by 38 additional patients bringing it to 288. The data readout in the next several months of the REMOVE study will be the big 'needle mover' assuming that the results are positive and statistically significant.
ClinicalTrials.gov Identifier: NCT04309591
Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis
Actual Study Start Date : October 18, 2019
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : December 4, 2019
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