Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DX-88/16 | Other Identifier | Cubist Study Number |
Not provided
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Experience gained from this study is sufficient to design and facilitate the follow-on study.
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The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement.
The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.
This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG, single valve repair, or single valve replacement. Participants were randomized in a 3:3:2 ratio to ecallantide high-dose regimen (maximum 91 mg), ecallantide low-dose regimen (maximum 15 mg), or placebo. Randomization was stratified by surgical procedure so that participants undergoing valve replacement would be evenly distributed across treatment arms. Each participant received active drug or placebo administered in stages on the day of the surgical procedure after induction of anesthesia (Day 1).
Participants were screened up to 14 days prior to surgery. Additional study procedures were conducted on Day -1 or 1, peri-operatively, during the immediate postoperative period, and on Days 2, 4, and 7 (or at the time of discharge from the hospital), and between Days 28 and 43 (follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecallantide - Low Dose Regimen | Experimental | Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours. |
|
| Ecallantide - High Dose Regimen | Experimental | Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 milliliters per hour (mL/hr) for 4 hours. |
|
| Placebo | Placebo Comparator | Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecallantide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively | Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group. | Up to 12 hours post admission to intensive care unit (ICU) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Chest Tube Drainage at 24 Hours Postoperatively | Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group. | Up to 24 hours post admission to ICU |
| Number of Participants With Treatment-emergent Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Concomitant surgery including but not limited to atrial septal defect repair, multiple valve replacement, carotid endarterectomy, and combined CABG and valve procedure
Planned hypothermic CPB using temperatures less than 28 degrees Celsius
Weight <55 kilograms (kg)
Major end organ dysfunction, defined as:
Cardiac:
Renal: Serum creatinine > 1.5 milligrams per deciliter (mg/dL)
Hepatic: Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal
Hematologic:
Serious intercurrent illness or active infection
Previous exposure to ecallantide
Known allergy to ecallantide or any of its components, fentanyl, midazolam, isoflurane, propofol, morphine, heparin, or protamine
Autologous blood donation ≤ 30 days month prior to surgery
Known substance abuse within 6 months prior to surgery
Receipt of an investigational drug or device within 30 days prior to participation in the current study
Administration of:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew L Sternlicht, MD | Dyax Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Birmingham | Alabama | 35205 | United States | ||
| Mayo Clinic Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecallantide - Low Dose Regimen | Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
|
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| up to 28 days post admission to ICU |
| Pharmacokinetics: Area Under the Concentration Time Curve | Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L) | 1, 2, 4, and 8 hours after end of study drug infusion |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Gaston Memorial Hospital | Gastonia | North Carolina | 28054 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Texas Heart Institute | Houston | Texas | 77225 | United States |
| FG001 | Ecallantide - High Dose Regimen | Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours. |
| FG002 | Placebo | Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours. |
| Received at Least 1 Dose of Study Drug |
|
| Started Post-operative Period |
|
| Completed Post-operative Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ecallantide - Low Dose Regimen | Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours. |
| BG001 | Ecallantide - High Dose Regimen | Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours. |
| BG002 | Placebo | Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively | Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group. | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Milliliters | Up to 12 hours post admission to intensive care unit (ICU) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Cumulative Chest Tube Drainage at 24 Hours Postoperatively | Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group. | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Milliliters | Up to 24 hours post admission to ICU |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All participants who received at least 1 dose of study drug. | Posted | Number | participants | up to 28 days post admission to ICU |
| ||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Area Under the Concentration Time Curve | Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L) | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mg*h/L | 1, 2, 4, and 8 hours after end of study drug infusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecallantide - Low Dose Regimen | Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours. | 9 | 26 | 25 | 26 | ||
| EG001 | Ecallantide - High Dose Regimen | Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours. | 4 | 25 | 23 | 25 | ||
| EG002 | Placebo | Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours. | 7 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 10.0 | Systematic Assessment | Resulted in one death |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bundle branch block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Retinal vascular thrombosis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Crepitations | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Postoperative respiratory distress | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac enzymes increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Electrocardiogram | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Mean arterial pressure decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Oxygen saturation normal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Thoracic cavity drainage test abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Electrolyte depletion | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Staring | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Incisional drainage | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Oxygen supplementation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | (781) 860-8660 |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C511194 | ecallantide |
Not provided
Not provided
Not provided
| BTWN |
|
| GTE65 |
|
| Male |
|
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|