Phase 2
Completed N=276
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Bloodloss · Surgical Procedures, Operative
Source: ClinicalTrials.gov NCT00816023 ↗
Enrolled (actual)
276
Serious AEs
27.3%
Results posted
Jan 2011
Primary outcomePrimary: Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery — 401.9; 383.1; 410.3; 377.6 mL — p=0.474
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery |
401.9; 383.1; 410.3; 377.6 | 0.474 |
| SECONDARY Treatment-emergent Adverse Events |
65; 59; 62; 63; 7; 9 | — |
Eligibility Criteria
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 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 1.5 X normal range;
- Serious intercurrent illness or active infection;
- Any previous exposure to ecallantide;
- Receipt of an investigational drug or device 30 days prior to participation in the current study;
- Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
- Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban HCl within 6 hours prior to surgery, *Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery, Clopidogrel within 5 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, *Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery, *Fondaparinux within 72 hours prior to surgery, Prasugrel within 10 days prior to surgery [*Prophylactic use permitted for the prevention of deep vein thrombosis.]
Data sourced from ClinicalTrials.gov (NCT00816023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.