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 States, Canada276 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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)