Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
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| ClinicalTrials.gov Identifier: NCT01530399 |
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Recruitment Status :
Terminated
(Safety)
First Posted : February 9, 2012
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
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Sponsor:
The Medicines Company
Information provided by (Responsible Party):
The Medicines Company
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, 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 |
| Enrollment | 44 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | MDCO 1 | MDCO 2 | MDCO 3 | MDCO 4 | Saline | Tranexamic Acid |
|---|---|---|---|---|---|---|
 Arm/Group Description |
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-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-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-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 | 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. | 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. |
| Period Title: Overall Study | ||||||
| Started | 8 | 10 | 8 | 10 | 6 | 7 |
| Completed | 7 | 8 | 7 | 10 | 6 | 6 |
| Not Completed | 1 | 2 | 1 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | MDCO 1 | MDCO 2 | MDCO 3 | MDCO 4 | Saline | Tranexamic Acid | Total | |
|---|---|---|---|---|---|---|---|---|
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Arm/Group Description |
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-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-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-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 | 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. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 8 | 10 | 8 | 10 | 6 | 7 | 49 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
||||||||
| Number Analyzed | 8 participants | 10 participants | 8 participants | 10 participants | 6 participants | 7 participants | 49 participants | |
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71
(64 to 75)
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70
(57 to 73)
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66
(60 to 79)
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73
(68 to 73)
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66
(60 to 71)
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58
(52 to 62)
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69
(61 to 73)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 8 participants | 10 participants | 8 participants | 10 participants | 6 participants | 7 participants | 49 participants | |
| Female |
1 12.5%
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2 20.0%
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1 12.5%
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2 20.0%
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2 33.3%
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0 0.0%
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8 16.3%
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| Male |
7 87.5%
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8 80.0%
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7 87.5%
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8 80.0%
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4 66.7%
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7 100.0%
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41 83.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 8 participants | 10 participants | 8 participants | 10 participants | 6 participants | 7 participants | 49 participants |
| Germany | 6 | 7 | 5 | 7 | 4 | 4 | 33 | |
| Switzerland | 2 | 3 | 3 | 3 | 2 | 3 | 16 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
After initial multicenter results communications are published, or after 12 months from study closure (whichever occurs first), sponsor can review results communications prior to submission and can embargo submissions for a period of 45 days from the time submitted to the sponsor for review, agreeing to resolve differences of opinion or interpretation through scientific debate. Sponsor can request further delay for an additional 90 days to file any patent applications if deemed necessary
Results Point of Contact
| Name/Title: | Peter Villiger |
| Organization: | TMC |
| Phone: | +19732906340 |
| EMail: | peter.villiger@themedco.com |
| Responsible Party: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT01530399 |
| Other Study ID Numbers: |
TMC-MDC-11-01 |
| First Submitted: | February 7, 2012 |
| First Posted: | February 9, 2012 |
| Results First Submitted: | November 4, 2015 |
| Results First Posted: | December 10, 2015 |
| Last Update Posted: | December 10, 2015 |