NCT00816023

A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bloodloss
• Surgical Procedures, Operative

Interventions

Type	Name	Description
DRUG	ecallantide	infusion administered IV over the duration of the surgical procedure
DRUG	placebo	solution for IV infusion over the duration of the surgical\>\> procedure

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-12-31
• Last updated: 2015-08-11
• Results posted: 2011-01-12

Locations

29 sites across 2 countries: United States, Canada