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DX-88 (Ecallantide) for the Reduction of Blood Loss Associated With Cardiopulmonary Bypass: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in Patients Undergoing Primary Cor

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Trial Conditions
  • Blood Loss, Surgical
What is the purpose of this trial?

The purpose of this study is to evaluate two different dose regimens of ecallantide to determine whether either or both dose regimens reduce blood loss, measured by chest tube drainage, compared to placebo during cardiopulmonary bypass surgery.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18  - 79 

Gender:
Both

Eligibility

Inclusion Criteria:

- Men and women age 18 to 79

- Elective primary CABG, single valve repair, or single valve replacement requiring CPB
and sternotomy

- No plan to use desmopressin acetate (DDAVP), atrial natriuretic hormone, EACA,
tranexamic acid or aprotinin during or postoperatively

- Female patients must be non-lactating and not pregnant

- If of childbearing potential, female patients must agree to use adequate
contraception for 1 month after receiving study drug

Exclusion Criteria:

- Concomitant surgery

- Planned hypothermic CPB using temperatures less than 28C

- Weight < 55 kg

- Major end organ dysfunction

- Serious intercurrent illness or active infection

- Previous exposure to DX-88 (ecallantide)

- Known allergy to ecallantide or any of its components, fentanyl, midazolam,
isoflurane, propofol, morphine, heparin or protamine

- Autologous blood donation ≤ 30 days month prior to surgery

- Known substance abuse

- Receipt of an investigational drug or device within 30 days prior to surgery

- Administration prior to surgery of Eptifibatide, Tirofiban HCl, enoxaparin sodium or
other low molecular weight heparin, Clopidogrel, Warfarin, Ticlopidine, Abciximab

Gender: Both
Steward Physician(s)
  • Andrew L Sternlicht, MD
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Drug
  • ecallantide
  • placebo
Physician Researcher

Investigator Name:

  • Andrew L Sternlicht, MD

Other Information

Sponsor: Cubist Pharmaceuticals
Phase: Phase 2
Trial ID: NCT00448864
Volunteers:  Not Accepting Healthy Volunteers

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