Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery (CONSERV-2)

This study has been completed.

Sponsor:

Information provided by:

Cubist Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00888940

First received: April 26, 2009

Last updated: May 24, 2011

Last verified: May 2011

History of Changes

Results First Received: December 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Bloodloss Surgical Procedures, Operative
Interventions:	Drug: Ecallantide Drug: Cyklokapron(R)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ecallantide	2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
Cyklokapron(R)	1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

Participant Flow: Overall Study

	Ecallantide	Cyklokapron(R)
STARTED	120	122
Completed Therapy	107	106
COMPLETED	92	101
NOT COMPLETED	28	21
Adverse Event	12	3
Lost to Follow-up	5	5
Randomized Not Treated	11	13

Baseline Characteristics

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Reporting Groups

	Description
Ecallantide	2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
Cyklokapron(R)	1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
Total	Total of all reporting groups

Baseline Measures

	Ecallantide	Cyklokapron(R)	Total
Number of Participants [units: participants]	120	122	242
Age [units: years] Mean ± Standard Deviation	69.6 ± 8.02	66.9 ± 10.88	68.2 ± 9.65
Gender [units: participants]
Female	45	50	95
Male	75	72	147
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	120	122	242

Outcome Measures

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1. Primary:

Cumulative Volume of Packed Red Blood Cells Transfused [ Time Frame: 12 hours after the end of surgery ]

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2. Secondary:

Treatment-emergent Adverse Events. [ Time Frame: Over the duration of the study. ]

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Measure Type	Secondary
Measure Title	Treatment-emergent Adverse Events.
Measure Description	No text entered.
Time Frame	Over the duration of the study.
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population analyzed

Reporting Groups

	Description
Ecallantide	2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
Cyklokapron(R)	1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

Measured Values

	Ecallantide	Cyklokapron(R)
Number of Participants Analyzed [units: participants]	109	109
Treatment-emergent Adverse Events. [units: events]
At Least 1 TEAE	100	94
At Least 1 Related TEAE	5	5
At Least 1 Severe TEAE	38	17
At Least 1 Serious TEAE	45	28
At Least 1 Related & Serious TEAE	4	1
Premature Study Drug Discontinuations Due to TEAE	2	2
Related TEAE Resulting in Discontinuation of Drug	0	0
TEAE Resulting in Death	13	4
Related TEAE Resulting in Death	0	0

No statistical analysis provided for Treatment-emergent Adverse Events.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The first publication is initiated by Cubist. If the First Publication is not published within 1 year of Study conclusion or termination, Investigator shall have the right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alistair Wheeler, MD MFPM, Senior Director Clinical Research
Organization: Cubist Pharmaceuticals, Inc.
phone: 781-860-8660
e-mail: awheeler@cubist.com

No publications provided by Cubist Pharmaceuticals

Publications automatically indexed to this study:

Bokesch PM, Szabo G, Wojdyga R, Grocott HP, Smith PK, Mazer CD, Vetticaden S, Wheeler A, Levy JH. A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial). J Thorac Cardiovasc Surg. 2012 May;143(5):1022-9. Epub 2011 Jul 2.

Responsible Party:	Edward Campanaro, Vice President Clinical Operations and Data Management, Cubist Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00888940 History of Changes
Other Study ID Numbers:	ECAL-CCPB-08-07
Study First Received:	April 26, 2009
Results First Received:	December 14, 2010
Last Updated:	May 24, 2011
Health Authority:	United States: Food and Drug Administration

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