NCT00888940

Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (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

A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding

Conditions

• Bloodloss
• Surgical Procedures, Operative

Interventions

Type	Name	Description
DRUG	Ecallantide	2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
DRUG	Cyklokapron(R)	1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-04-28
• Last updated: 2015-08-10
• Results posted: 2011-01-17

Locations

34 sites across 3 countries: United States, Germany, Poland