BloodlossPhase 2CONSERV-1NCT00816023

A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

A Phase 2 study testing ecallantide in people with Bloodloss and Surgical Procedures, Operative, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Bloodloss, Surgical Procedures, Operative
What is being tested?: ecallantide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 276 participants
Where: 29 sitesin 2 countries
Study dates: Mar 2009to Jan 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.]

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States21 sites

University of Colorado - Denver
Aurora, Colorado, 80045
Cardio-Thoracic Surgeons PC
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25304
Duke University Medical Center
Durham, North Carolina, 27710
Indiana Ohio Heart
Fort Wayne, Indiana, 46804
Texas Heart Institute
Houston, Texas, 77030
East Tennessee Cardiovascular Surgery Group
Knoxville, Tennessee, 37920
University of Kentucky
Lexington, Kentucky, 40536
Drug Research and Analysis Corporation
Montgomery, Alabama, 36106
St. Luke's - Roosevelt Hospital Center
New York, New York, 10025
Weill Medical College of Cornell University
New York, New York, 10065
Sentara Heart Hospital
Norfolk, Virginia, 23507
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55901
MCVI - Covenant Medical Center
Saginaw, Michigan, 48601
MCVI - St. Mary's of Michigan
Saginaw, Michigan, 48601
Pepin Heart Hospital & Kiran Patel Research Institute
Tampa, Florida, 33613

Other trials in United States

Canada8 sites

Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Hamilton Health Sciences
Hamilton, Ontario, L8L 5G4
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)
Québec, Quebec, G1V 4G5
New Brunswick Heart Centre
Saint John, New Brunswick, E2L 4L2
St. Michael's Hospital
Toronto, Ontario, M5B 18W
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

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

Conditions: Bloodloss, Surgical Procedures, Operative
Being tested: ecallantide, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ecallantideDrug
infusion administered IV over the duration of the surgical procedure
placeboDrug
solution for IV infusion over the duration of the surgical>> procedure

Study groups in NCT00816023
Study group	Role	What they receive
Ecallantide Low Dose	Experimental	target steady state concentration of 0.15 mg/L Receives: Drug: ecallantide
Ecallantide Medium Dose	Experimental	target steady state concentration of 0.75 mg/L Receives: Drug: ecallantide
Ecallantide High Dose	Experimental	target steady state concentration of 2.25 mg/L Receives: Drug: ecallantide
Placebo	Placebo comparator	placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
Measured: Start of surgery up to 12 hours after the end of surgery

Secondary outcomes (1)

Treatment-emergent Adverse Events
Measured: Over the duration of the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jan 2010

First posted31 Dec 2008 (estimated)
Study startMar 2009
Primary completionDec 2009
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BloodlossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00816023
Sponsor's protocol ID: ECAL-PCPB-08-02
Acronym: CONSERV-1
Status last verified: Jul 2015
First submitted: 29 Dec 2008
Last updated: 11 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00816023
Acronym / sponsor ID: CONSERV-1 / ECAL-PCPB-08-02
Conditions: Bloodloss, Surgical Procedures, Operative
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 31 Dec 2008 (estimated)
Results: Posted 12 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ecallantide Low Dose	Experimental	Drug: ecallantidetarget steady state concentration of 0.15 mg/L
Ecallantide Medium Dose	Experimental	Drug: ecallantidetarget steady state concentration of 0.75 mg/L
Ecallantide High Dose	Experimental	Drug: ecallantidetarget steady state concentration of 2.25 mg/L
Placebo	Placebo comparator	Drug: placeboplacebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (24 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ecallantideinfusion administered IV over the duration of the surgical procedure	Drug	Ecallantide High Dose, Ecallantide Low Dose, Ecallantide Medium Dose
placebosolution for IV infusion over the duration of the surgical>> procedure	Drug	Placebo

Primary outcome

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

1 secondary outcome

Treatment-emergent Adverse Events
Time frame: Over the duration of the study.

Results and safety

Results posted to the registry on 12 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ecallantide Low Dose	71	62
Ecallantide Medium Dose	62	56
Ecallantide High Dose	69	60
Placebo	74	62

Primary outcome: 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. Mean (Standard Deviation). Unit: mL

Measure	Ecallantide Low Dose n = 65	Ecallantide Medium Dose n = 58	Ecallantide High Dose n = 63	Placebo n = 63
Value	401.9 (624.87)	383.1 (620.62)	410.3 (639.47)	377.6 (608.54)

Ecallantide Low Dose vs Ecallantide Medium Dose vs Ecallantide High Dose vs Placebo: p = 0.474, Jonckheere-Terpstra

Population analysed: The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECALLANTIDE HIGH DOSE	19 of 62 (30.6%)	62 of 62 (100%)	Not reported
ECALLANTIDE MEDIUM DOSE	19 of 59 (32.2%)	59 of 59 (100%)	Not reported
ECALLANTIDE LOW DOSE	15 of 65 (23.1%)	65 of 65 (100%)	Not reported
PLACEBO	15 of 63 (23.8%)	63 of 63 (100%)	Not reported

Limitations and caveats (from the sponsor): Secondary efficacy variables were considered exploratory and, based on failure of the primary endpoint to meet statistical significance and early termination of the trial, are not presented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alistair Wheeler, MD, MFPM study director

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00816023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.