Trial Outcomes & Findings for Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (NCT NCT00913133)
NCT ID: NCT00913133
Last Updated: 2013-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
516 participants
Primary outcome timeframe
24 hours after last dose of study drug
Results posted on
2013-01-10
Participant Flow
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.
Participant milestones
| Measure |
Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Overall Study
STARTED
|
516
|
|
Overall Study
COMPLETED
|
516
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Baseline characteristics by cohort
| Measure |
Desirudin
n=516 Participants
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
387 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
129 Participants
n=39 Participants
|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 14.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
516 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 24 hours after last dose of study drugPopulation: All patients receiving at least one dose of study drug
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.
Outcome measures
| Measure |
Desirudin
n=516 Participants
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Major Bleeding
|
0 participants
|
SECONDARY outcome
Timeframe: Up until 24 hours after last dose of study drugPopulation: Patients who received at least one dose of study drug
* New onset symptomatic thrombosis requiring medical or surgical intervention; * Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction.
Outcome measures
| Measure |
Desirudin
n=516 Participants
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Thrombosis
|
8 participants
|
Adverse Events
Desirudin
Serious events: 80 serious events
Other events: 382 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desirudin
n=516 participants at risk
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Gastrointestinal disorders
pancreatic pseudocyst
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
rectal hemorrhage
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Blood and lymphatic system disorders
anemia
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Blood and lymphatic system disorders
leukopenia
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
acute myocardial infarction
|
0.78%
4/516 • Number of events 4 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
atrial fibrillation
|
0.97%
5/516 • Number of events 5 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
cardiac failure congestive
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
cardiogenic shock
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
coronary artery disease
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
abdominal distension
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
abdominal pain
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
colonic obstruction
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
constipation
|
0.58%
3/516 • Number of events 3 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
gastric hemorrhage
|
0.78%
4/516 • Number of events 4 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
gastrointestinal necrosis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
hematemesis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
ileus
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
nausea
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
small intestinal obstruction
|
1.4%
7/516 • Number of events 7 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
vomiting
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
General disorders
asthenia
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
General disorders
multi-organ failure
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
abdominal abscess
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
abdominal sepsis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
bacterial infection
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
cellulitis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
clostridium difficile colitis
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Infections and infestations
diverticulitis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
osteomyelitis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
pelvic abscess
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
peridiverticular abscess
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
pneumonia
|
0.39%
2/516 • Number of events 2 • up to 30 days after cessation of study drug
|
|
Infections and infestations
post-procedural infection
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
sepsis
|
0.58%
3/516 • Number of events 3 • up to 30 days after cessation of study drug
|
|
Infections and infestations
septic shock
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Infections and infestations
wound infection
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
gatrointestinal disorder postoperative
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
gastrointestinal stoma complication
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
graft thrombosis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
postoperative ileus
|
0.97%
5/516 • Number of events 5 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
procedural nausea
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
procedural site reaction
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
procedural vomiting
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
splenic hematoma
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
subdural hematoma
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Investigations
white blood cell count increased
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
dehydration
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder cancer
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm malignant
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
plasmacytoma
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Nervous system disorders
embolic stroke
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Nervous system disorders
syncope
|
0.58%
3/516 • Number of events 3 • up to 30 days after cessation of study drug
|
|
Renal and urinary disorders
hydronephrosis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Renal and urinary disorders
renal failure
|
0.58%
3/516 • Number of events 3 • up to 30 days after cessation of study drug
|
|
Renal and urinary disorders
renal failure acute
|
0.97%
5/516 • Number of events 5 • up to 30 days after cessation of study drug
|
|
Renal and urinary disorders
uretic obstruction
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Reproductive system and breast disorders
pelvic fluid collection
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Reproductive system and breast disorders
pelvic pain
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Reproductive system and breast disorders
vaginal hemorrhage
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
bronchial secretion retention
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
diaphragmatic hernia
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.78%
4/516 • Number of events 4 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.78%
4/516 • Number of events 4 • up to 30 days after cessation of study drug
|
|
Surgical and medical procedures
cholecystectomy
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
|
Vascular disorders
deep vein thrombosis
|
0.58%
3/516 • Number of events 3 • up to 30 days after cessation of study drug
|
|
Vascular disorders
haematoma
|
0.19%
1/516 • Number of events 1 • up to 30 days after cessation of study drug
|
Other adverse events
| Measure |
Desirudin
n=516 participants at risk
desirudin 15 mg twice daily for a minimum of 5 days
|
|---|---|
|
Gastrointestinal disorders
constipation
|
14.7%
76/516 • Number of events 76 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
nausea
|
14.7%
76/516 • Number of events 76 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
procedural pain
|
11.4%
59/516 • Number of events 59 • up to 30 days after cessation of study drug
|
|
Blood and lymphatic system disorders
anemia
|
8.7%
45/516 • Number of events 45 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
breath sounds abnormal
|
7.9%
41/516 • Number of events 41 • up to 30 days after cessation of study drug
|
|
General disorders
pyrexia
|
7.6%
39/516 • Number of events 39 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
7.4%
38/516 • Number of events 38 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
tachycardia
|
7.2%
37/516 • Number of events 37 • up to 30 days after cessation of study drug
|
|
General disorders
asthenia
|
7.0%
36/516 • Number of events 36 • up to 30 days after cessation of study drug
|
|
Injury, poisoning and procedural complications
anemia postoperative
|
6.4%
33/516 • Number of events 33 • up to 30 days after cessation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
oxygen saturation decrease
|
6.2%
32/516 • Number of events 32 • up to 30 days after cessation of study drug
|
|
Vascular disorders
oedema peripheral
|
6.0%
31/516 • Number of events 31 • up to 30 days after cessation of study drug
|
|
Gastrointestinal disorders
vomiting
|
6.0%
31/516 • Number of events 31 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
hyperglycemia
|
5.8%
30/516 • Number of events 30 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.2%
27/516 • Number of events 27 • up to 30 days after cessation of study drug
|
|
Cardiac disorders
hypotension
|
5.2%
27/516 • Number of events 27 • up to 30 days after cessation of study drug
|
|
General disorders
generalised oedema
|
5.0%
26/516 • Number of events 26 • up to 30 days after cessation of study drug
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.0%
26/516 • Number of events 26 • up to 30 days after cessation of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60