drugset / Trial / 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

Phase 2 Completed 243 enrolled Merck & Co., Inc.

RandomizedParallel-groupQuadruple-blindPrevention

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

Timeline

Start: 2009-06
Primary completion: 2009-12
Completion: 2010-01

Outcome

Missed primary endpoint

registry MEAN Ecallantide: 1223.2 (Standard Deviation 1334.57) mL MEAN Cyklokapron(R): 623.5 (Standard Deviation 974.64) mL analysis (superiority or other test); Ecallantide vs Cyklokapron(R); p = 0.001; Wilcoxon (Mann-Whitney) NCT00888940 ↗

paper Patients receiving ecallantide received more packed red blood cells within 12 hours of surgery than tranexamic acid-treated patients: median = 900 mL (95% confidence interval, 600-1070) versus 300 mL (95% confidence interval, 0-523) (P < .001). PMID 21724197 ↗

paper CONCLUSIONS: Ecallantide was less effective at reducing perioperative blood loss than tranexamic acid. PMID 21724197 ↗

Publications

Bokesch PM, Szabo G, Wojdyga R, Grocott HP, Smith PK, Mazer CD, Vetticaden S, Wheeler A, Levy JH. A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial). J Thorac Cardiovasc Surg. 2012 May;143(5):1022-9. doi: 10.1016/j.jtcvs.2011.06.001. Epub 2011 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyklokapron(R)	Unknown	400 mg	—
Subject	ecallantide	Protein / enzyme biologic	0.00225 mg/ml	—

Indications

No indication recorded.