Trial Outcomes & Findings for Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery (NCT NCT01530399)
NCT ID: NCT01530399
Last Updated: 2015-12-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
12 hours post CABG
Results posted on
2015-12-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
8
|
10
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
10
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
Baseline characteristics by cohort
| Measure |
MDCO 1
n=8 Participants
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
n=10 Participants
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
n=8 Participants
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
n=10 Participants
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
n=6 Participants
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
n=7 Participants
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
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=113 Participants
|
70 years
n=163 Participants
|
66 years
n=160 Participants
|
73 years
n=483 Participants
|
66 years
n=36 Participants
|
58 years
n=10 Participants
|
69 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
8 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=113 Participants
|
7 participants
n=163 Participants
|
5 participants
n=160 Participants
|
7 participants
n=483 Participants
|
4 participants
n=36 Participants
|
4 participants
n=10 Participants
|
33 participants
n=115 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=113 Participants
|
3 participants
n=163 Participants
|
3 participants
n=160 Participants
|
3 participants
n=483 Participants
|
2 participants
n=36 Participants
|
3 participants
n=10 Participants
|
16 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 12 hours post CABGOutcome measures
| Measure |
MDCO 1
n=7 Participants
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
n=7 Participants
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
n=6 Participants
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
n=10 Participants
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
n=6 Participants
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
n=6 Participants
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.
|
|---|---|---|---|---|---|---|
|
Chest Tube Drainage at 12 Hours After Surgery
|
600 mL
Interval 300.0 to 970.0
|
580 mL
Interval 420.0 to 880.0
|
480 mL
Interval 350.0 to 700.0
|
453 mL
Interval 415.0 to 645.0
|
645 mL
Interval 400.0 to 1040.0
|
593 mL
Interval 530.0 to 750.0
|
Adverse Events
MDCO 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
MDCO 2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
MDCO 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MDCO 4
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Tranexamic Acid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MDCO 1
n=7 participants at risk
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
n=8 participants at risk
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
n=7 participants at risk
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
n=10 participants at risk
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
n=6 participants at risk
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
n=6 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/7 • 30 (+5) days post treatment
|
12.5%
1/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/7 • 30 (+5) days post treatment
|
12.5%
1/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/7 • 30 (+5) days post treatment
|
12.5%
1/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Nervous system disorders
Ischaemic stroke
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Renal and urinary disorders
Renal failure
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Vascular disorders
Extremity necrosis
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
Other adverse events
| Measure |
MDCO 1
n=7 participants at risk
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
n=8 participants at risk
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
n=7 participants at risk
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
n=10 participants at risk
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
n=6 participants at risk
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
n=6 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
42.9%
3/7 • 30 (+5) days post treatment
|
25.0%
2/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
16.7%
1/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • 30 (+5) days post treatment
|
25.0%
2/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
20.0%
2/10 • 30 (+5) days post treatment
|
16.7%
1/6 • 30 (+5) days post treatment
|
33.3%
2/6 • 30 (+5) days post treatment
|
|
Blood and lymphatic system disorders
Troponin T increased
|
14.3%
1/7 • 30 (+5) days post treatment
|
25.0%
2/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • 30 (+5) days post treatment
|
12.5%
1/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
10.0%
1/10 • 30 (+5) days post treatment
|
33.3%
2/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
20.0%
2/10 • 30 (+5) days post treatment
|
33.3%
2/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • 30 (+5) days post treatment
|
25.0%
2/8 • 30 (+5) days post treatment
|
14.3%
1/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Hepatobiliary disorders
AST increased
|
0.00%
0/7 • 30 (+5) days post treatment
|
25.0%
2/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
|
Gastrointestinal disorders
AST increased
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/8 • 30 (+5) days post treatment
|
0.00%
0/7 • 30 (+5) days post treatment
|
0.00%
0/10 • 30 (+5) days post treatment
|
0.00%
0/6 • 30 (+5) days post treatment
|
33.3%
2/6 • 30 (+5) days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER