A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume (CONSERV-1)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00816023 |
|
Recruitment Status :
Completed
First Posted : December 31, 2008
Results First Posted : January 12, 2011
Last Update Posted : August 11, 2015
|
Sponsor:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bloodloss Surgical Procedures, Operative | Drug: ecallantide Drug: placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 276 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | 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 to Cardio-pulmonary Bypass During Primary Coronary Artery Bypass Graft Surgery |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | January 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bleeding
Drug Information available for:
Ecallantide
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Ecallantide Low Dose
target steady state concentration of 0.15 mg/L
|
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure |
|
Experimental: Ecallantide Medium Dose
target steady state concentration of 0.75 mg/L
|
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure |
|
Experimental: Ecallantide High Dose
target steady state concentration of 2.25 mg/L
|
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure |
|
Placebo Comparator: Placebo
placebo
|
Drug: placebo
solution for IV infusion over the duration of the surgical>> procedure |
Primary Outcome Measures :
- Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery [ Time Frame: Start of surgery up to 12 hours after the end of surgery ]
Secondary Outcome Measures :
- Treatment-emergent Adverse Events [ Time Frame: Over the duration of the study. ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <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.]
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816023
Locations
Show 29 study locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
| Study Director: | Alistair Wheeler, MD, MFPM | Cubist Pharmaceuticals LLC |
| Responsible Party: | Cubist Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT00816023 |
| Other Study ID Numbers: |
ECAL-PCPB-08-02 |
| First Posted: | December 31, 2008 Key Record Dates |
| Results First Posted: | January 12, 2011 |
| Last Update Posted: | August 11, 2015 |
| Last Verified: | July 2015 |
Additional relevant MeSH terms:
|
Blood Loss, Surgical Hemorrhage Pathologic Processes Intraoperative Complications Ecallantide Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |