Trial Outcomes & Findings for 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 (NCT NCT00888940)
NCT ID: NCT00888940
Last Updated: 2015-08-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
12 hours after the end of surgery
Results posted on
2015-08-10
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
122
|
|
Overall Study
Completed Therapy
|
107
|
106
|
|
Overall Study
COMPLETED
|
92
|
101
|
|
Overall Study
NOT COMPLETED
|
28
|
21
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Randomized Not Treated
|
11
|
13
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Ecallantide
n=120 Participants
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
|
Cyklokapron(R)
n=122 Participants
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 10.88 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours after the end of surgeryPopulation: Modified Intent to Treat = all subjects received at least one dose and analyzed according to planned treatment assignment. 3 subjects in ecallantide group not included due to no value being present
Outcome measures
| Measure |
Ecallantide
n=106 Participants
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
|
Cyklokapron(R)
n=109 Participants
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
|
|---|---|---|
|
Cumulative Volume of Packed Red Blood Cells Transfused
|
1223.2 mL
Standard Deviation 1334.57
|
623.5 mL
Standard Deviation 974.64
|
SECONDARY outcome
Timeframe: Over the duration of the study.Population: Safety population analyzed
Outcome measures
| Measure |
Ecallantide
n=109 Participants
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
|
Cyklokapron(R)
n=109 Participants
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
|
|---|---|---|
|
Treatment-emergent Adverse Events.
At Least 1 TEAE
|
100 events
|
94 events
|
|
Treatment-emergent Adverse Events.
At Least 1 Related TEAE
|
5 events
|
5 events
|
|
Treatment-emergent Adverse Events.
At Least 1 Severe TEAE
|
38 events
|
17 events
|
|
Treatment-emergent Adverse Events.
At Least 1 Serious TEAE
|
45 events
|
28 events
|
|
Treatment-emergent Adverse Events.
At Least 1 Related & Serious TEAE
|
4 events
|
1 events
|
|
Treatment-emergent Adverse Events.
Premature Study Drug Discontinuations Due to TEAE
|
2 events
|
2 events
|
|
Treatment-emergent Adverse Events.
Related TEAE Resulting in Discontinuation of Drug
|
0 events
|
0 events
|
|
Treatment-emergent Adverse Events.
TEAE Resulting in Death
|
13 events
|
4 events
|
|
Treatment-emergent Adverse Events.
Related TEAE Resulting in Death
|
0 events
|
0 events
|
Adverse Events
Ecallantide
Serious events: 45 serious events
Other events: 93 other events
Deaths: 0 deaths
Cyklokapron
Serious events: 28 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ecallantide
n=109 participants at risk
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
|
Cyklokapron
n=109 participants at risk
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
2/109 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
1.8%
2/109 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Cardiac arrest
|
3.7%
4/109 • Number of events 4
|
0.00%
0/109
|
|
Cardiac disorders
Cardiac failure
|
2.8%
3/109 • Number of events 3
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
3.7%
4/109 • Number of events 4
|
2.8%
3/109 • Number of events 3
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
2/109 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Myocardial ischaemia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Right ventricular failure
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Sick sinus syndrome
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Ventricle rupture
|
3.7%
4/109 • Number of events 4
|
0.00%
0/109
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
3.7%
4/109 • Number of events 4
|
0.00%
0/109
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
2/109 • Number of events 2
|
0.00%
0/109
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Impaired healing
|
1.8%
2/109 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Multi-organ failure
|
2.8%
3/109 • Number of events 3
|
1.8%
2/109 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Pseudomembranous colitis
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Sepsis
|
0.92%
1/109 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Staphylococcal sepsis
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Stenotrophomonas infection
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Infections and infestations
Wound infection
|
0.00%
0/109
|
1.8%
2/109 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.92%
1/109 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
10.1%
11/109 • Number of events 13
|
6.4%
7/109 • Number of events 7
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
2.8%
3/109 • Number of events 3
|
0.00%
0/109
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Investigations
Cardiac output decreased
|
1.8%
2/109 • Number of events 2
|
0.00%
0/109
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/109
|
1.8%
2/109 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Nervous system disorders
Hypoxic encephalopathy
|
1.8%
2/109 • Number of events 2
|
0.00%
0/109
|
|
Nervous system disorders
Neurological decompensation
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Psychiatric disorders
Impaired self-care
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/109 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
0.92%
1/109 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
2/109 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.6%
5/109 • Number of events 5
|
3.7%
4/109 • Number of events 4
|
|
Vascular disorders
Air embolism
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
|
Vascular disorders
Haemorrhage
|
8.3%
9/109 • Number of events 9
|
0.00%
0/109
|
|
Vascular disorders
Hypotension
|
0.00%
0/109
|
0.92%
1/109 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/109
|
Other adverse events
| Measure |
Ecallantide
n=109 participants at risk
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
|
Cyklokapron
n=109 participants at risk
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.5%
18/109 • Number of events 18
|
14.7%
16/109 • Number of events 17
|
|
Cardiac disorders
Arrhythmia
|
6.4%
7/109 • Number of events 7
|
4.6%
5/109 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
29.4%
32/109 • Number of events 32
|
17.4%
19/109 • Number of events 20
|
|
Cardiac disorders
Tachycardia
|
2.8%
3/109 • Number of events 3
|
8.3%
9/109 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
8.3%
9/109 • Number of events 9
|
9.2%
10/109 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/109 • Number of events 4
|
7.3%
8/109 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
5.5%
6/109 • Number of events 6
|
8.3%
9/109 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
7/109 • Number of events 8
|
3.7%
4/109 • Number of events 4
|
|
General disorders
Impaired healing
|
5.5%
6/109 • Number of events 6
|
8.3%
9/109 • Number of events 9
|
|
General disorders
Non-cardiac chest pain
|
6.4%
7/109 • Number of events 9
|
8.3%
9/109 • Number of events 10
|
|
General disorders
Oedema peripheral
|
5.5%
6/109 • Number of events 6
|
6.4%
7/109 • Number of events 7
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.6%
17/109 • Number of events 18
|
22.9%
25/109 • Number of events 25
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.1%
11/109 • Number of events 11
|
13.8%
15/109 • Number of events 15
|
|
Psychiatric disorders
Sleep disorder
|
4.6%
5/109 • Number of events 5
|
5.5%
6/109 • Number of events 7
|
|
Psychiatric disorders
Transient psychosis
|
6.4%
7/109 • Number of events 7
|
3.7%
4/109 • Number of events 4
|
|
Renal and urinary disorders
Renal failure
|
2.8%
3/109 • Number of events 3
|
7.3%
8/109 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.8%
15/109 • Number of events 15
|
15.6%
17/109 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.8%
2/109 • Number of events 2
|
5.5%
6/109 • Number of events 6
|
|
Vascular disorders
Hypertension
|
5.5%
6/109 • Number of events 6
|
9.2%
10/109 • Number of events 10
|
|
Vascular disorders
Hypotension
|
18.3%
20/109 • Number of events 20
|
18.3%
20/109 • Number of events 20
|
Additional Information
Alistair Wheeler, MD MFPM, Senior Director Clinical Research
Cubist Pharmaceuticals, Inc.
Phone: 781-860-8660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER