At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 276 enrolled
Drug / intervention
ecallantide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CONSERV-1 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) A Phase 2 Randomized Placebo-controlled Dose-ranging Study in Subjects Exposed to Cardio-pulmonary Bypass During Primary Coronary Artery Bypass Graft Surgery
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Dec 31, 2008·Updated Aug 11, 2015
In Brief
A Phase 2 clinical trial evaluating ecallantide and placebo for Bloodloss and Surgical Procedures, Operative. Completed, enrolled 276 participants across 29 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBloodloss, Surgical Procedures, Operative
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartMar 2009
Primary CompletionDec 2009
Study CompletionJan 2010
TodayJul 2026
First PostedDec 31, 2008
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.5 years ago
Interventions
ecallantidedrug
infusion administered IV over the duration of the surgical procedure
placebodrug
solution for IV infusion over the duration of the surgical\>\> procedure