At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 243 enrolled
Drug / intervention
Ecallantide +1 moredrug
Likely dose
Ecallantide 2.25 mgfrom 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 - 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) - A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Apr 28, 2009·Updated Aug 10, 2015
In Brief
A Phase 2 clinical trial evaluating Ecallantide and Cyklokapron(R) for Bloodloss and Surgical Procedures, Operative. Completed, enrolled 243 participants across 34 sites in 3 countries.
Detailed Summary
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBloodloss, Surgical Procedures, Operative
CountriesGermany, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJun 2009
Primary CompletionDec 2009
Study CompletionJan 2010
TodayJul 2026
First PostedApr 28, 2009
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.2 years ago
Interventions
Ecallantidedrug
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
Cyklokapron(R)drug
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime