Return to Results

CONSERV-1 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) A Phase 2 Randomized Placebo-controlled Dose-ranging Study in Subjects Exposed

new search

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

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 85 

Gender:
Both

Eligibility

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 family history of, bleeding or clotting disorder or thrombophilia;

- History of heparin-induced thrombocytopenia;

- Prothrombin time and/or activated partial thromboplastin time >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.]

Gender: Both
Steward Physician(s)
  • Alistair Wheeler, MD, MFPM
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • ecallantide
  • placebo
Physician Researcher

Investigator Name:

  • Alistair Wheeler, MD, MFPM

Other Information

Sponsor: Cubist Pharmaceuticals
Phase: Phase 2
Trial ID: NCT00816023
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions