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The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desirudin | Experimental | desirudin 15 mg twice daily for a minimum of 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desirudin | Drug | Desirudin SC 15mg q12h |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint. | 24 hours after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis |
| Up until 24 hours after last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Bell, PharmD | Canyon Pharmaceuticals, Inc. | Study Director |
| Jerrold Levy, MD, FAHA | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Science Center | Aurora | Colorado | 80045 | United States | ||
| University of South Florida, Tampa General Hospital |
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Patients were recruited between April 5, 2010 and February 18, 2011. Patients were recruited from inpatient medical and surgical services as well as surgical clinics when presenting for pre-operative services.
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| ID | Title | Description |
|---|---|---|
| FG000 | Desirudin | desirudin 15 mg twice daily for a minimum of 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tampa |
| Florida |
| 33606 |
| United States |
| Saint Joseph's Research Institute | Atlanta | Georgia | 30342 | United States |
| Southeastern Center for Clinical Trials | Decatur | Georgia | 30033 | United States |
| Provena St. Joseph's Medical Center | Joliet | Illinois | 60435 | United States |
| Illinois Lung and Critical Care Institute | Peoria | Illinois | 61606 | United States |
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Overlook Hospital | Summit | New Jersey | 07901 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-8191 | United States |
| Forsyth Regional Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Forsyth Regional Medical Center | Winston-Salem | North Carolina | 55902 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102-1192 | United States |
| Research Concepts, Memorial Hermann Healthcare System | Houston | Texas | 77024 | United States |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desirudin | desirudin 15 mg twice daily for a minimum of 5 days |
| 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 |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Major Bleeding | Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint. | All patients receiving at least one dose of study drug | Posted | Number | participants | 24 hours after last dose of study drug |
|
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| ||||||||||||||||||||||||||
| Secondary | Thrombosis |
| Patients who received at least one dose of study drug | Posted | Number | participants | Up until 24 hours after last dose of study drug |
|
|
up to 30 days after cessation of study drug
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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 | Desirudin | desirudin 15 mg twice daily for a minimum of 5 days | 80 | 516 | 382 | 516 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| cardiogenic shock | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| colonic obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| gastric hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| gastrointestinal necrosis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| hematemesis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| ileus | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| pancreatic pseudocyst | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| rectal hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| multi-organ failure | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| cholecystitis acute | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
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| abdominal abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| abdominal sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| bacterial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| clostridium difficile colitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| diverticulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| osteomyelitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| pelvic abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| peridiverticular abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| post-procedural infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| septic shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| wound infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| gatrointestinal disorder postoperative | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| graft thrombosis | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| postoperative ileus | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| procedural nausea | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| procedural site reaction | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| procedural vomiting | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| splenic hematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| subdural hematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| white blood cell count increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| failure to thrive | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| embolic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| hydronephrosis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| uretic obstruction | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| pelvic fluid collection | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| pelvic pain | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| vaginal hemorrhage | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| cholecystectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| breath sounds abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| anemia postoperative | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| oxygen saturation decrease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| oedema peripheral | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| hypotension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| generalised oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
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| hypocalcemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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This was a multi-center, single-arm, observational safety trial. The lack of an active comparator does not allow us to make conclusions about the relative safety and efficacy of the product.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Canyon Pharmaceuticals | 888-434-7003 | info@canyonpharma.com |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C060225 | desirudin |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|