A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume (NCT00816023) | Clinical Trial Compass
CompletedPhase 2
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
United States276 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent (by study subject or appropriate legal representative) prior to any study-related procedure not part of normal medical care
* Planned primary CABG surgery including the use of cardio-pulmonary bypass.
Exclusion Criteria:
* Planned concomitant surgery including ASD repair, valve replacement, carotid endarterectomy, CABG combined procedures or any repeat sternotomy;
* Body weight \<55 kg;
* Planned hypothermia (\<28ºC);
* Planned transfusion in the peri-operative or post-operative periods;
* Planned transfusion of pre-operatively donated autologous blood;
* Female subjects who are pregnant or lactating;
* Planned use of desmopressin, lysine analogs, atrial natriuretic hormone or recombinant activated Factor VII;
* Planned use of corticosteroids in the pump prime solution;
* Ejection fraction \<30% within 90 days prior to surgery;
* Evidence of a myocardial infarction within 5 days prior to surgery;
* History of stroke or transient ischemic attack within 3 months prior to surgery;
* Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
* Serum creatinine \>2.0 mg/dL within 48 hours prior to surgery;
* Serum hepatic enzymes above 2.5 times the upper limit of normal for the applicable laboratory;
* Hematocrit \<32% within 48 hours prior to surgery;
* Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
* History of, or fami…
What they're measuring
1
Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
Timeframe: Start of surgery up to 12 hours after the end of surgery
Trial details
NCT IDNCT00816023
SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)