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Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery

This study has been terminated.
(Safety)
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01530399
First received: February 7, 2012
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bleeding
Interventions: Drug: MDCO 1
Drug: MDCO 2
Drug: MDCO 3
Drug: MDCO 4
Drug: Tranexamic Acid
Drug: Saline

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MDCO 1 MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
MDCO 2 MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
MDCO 3 MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
MDCO 4 MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
Saline Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
Tranexamic Acid saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.

Participant Flow:   Overall Study
    MDCO 1   MDCO 2   MDCO 3   MDCO 4   Saline   Tranexamic Acid
STARTED   8   10   8   10   6   7 
COMPLETED   7   8   7   10   6   6 
NOT COMPLETED   1   2   1   0   0   1 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
MDCO 1 MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
MDCO 2 MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
MDCO 3 MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
MDCO 4 MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
Saline Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
Tranexamic Acid saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
Total Total of all reporting groups

Baseline Measures
   MDCO 1   MDCO 2   MDCO 3   MDCO 4   Saline   Tranexamic Acid   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   10   8   10   6   7   49 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 71 
 (64 to 75) 
 70 
 (57 to 73) 
 66 
 (60 to 79) 
 73 
 (68 to 73) 
 66 
 (60 to 71) 
 58 
 (52 to 62) 
 69 
 (61 to 73) 
Gender 
[Units: Participants]
             
Female   1   2   1   2   2   0   8 
Male   7   8   7   8   4   7   41 
Region of Enrollment 
[Units: Participants]
             
Germany   6   7   5   7   4   4   33 
Switzerland   2   3   3   3   2   3   16 


  Outcome Measures

1.  Primary:   Chest Tube Drainage at 12 Hours After Surgery   [ Time Frame: 12 hours post CABG ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Peter Villiger
Organization: TMC
phone: +19732906340
e-mail: peter.villiger@themedco.com



Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01530399     History of Changes
Other Study ID Numbers: TMC-MDC-11-01
Study First Received: February 7, 2012
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices