CompletedNCT00913133DESIR-ABLEUpdated Jan 10, 2013Results posted

Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

A Phase 4 interventional study of Desirudin in Thrombosis, sponsored by Canyon Pharmaceuticals, Inc.. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Canyon Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 516
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Conditions studied

Thrombosis

Browse trials for

Thrombosis 1,528

Keywords

Anticoagulation
Prophylaxis
Desirudin
Direct thrombin inhibitor
Heparin-induced thrombocytopenia

In context

Thrombosis

1,528 studies on the registry are indexed under Thrombosis; 240 are open to participants now.

This study's enrollment of 516 is above the median of 107 across 866 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Canyon Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Provide written informed consent before initiation of any study related procedures.
Be at least 18 years of age.
Patients requiring anticoagulation for the prophylaxis of thrombosis.
In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

Exclusion criteria

Exclusion Criteria:

Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
Intracranial neoplasm, arteriovenous malformation or aneurysm.
Severe renal insufficiency (chronic or acute) with a GFR of \< or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
Refusal to undergo blood transfusion should it become necessary
Active bleeding or irreversible coagulation abnormality.
Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 516 participants (actual)

Study arms

Experimental
Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
Drug: Desirudin

Interventions

DrugDesirudin
Desirudin SC 15mg q12h
Also known as: Iprivask

What researchers measure

Primary outcomes

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.
Time frame: 24 hours after last dose of study drug

Secondary outcomes

Thrombosis
* 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.
Time frame: Up until 24 hours after last dose of study drug

Results

Posted Jan 3, 2013

Limitations and caveats

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.

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 flow — Overall Study
Milestone	Desirudin
Started	516
Completed	516
Not completed	0

Outcome measures

PrimaryMajor 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.

Time frame:: 24 hours after last dose of study drug
Reported as:: Number · participants

Major Bleeding
participants	Desirudin
Major Bleeding	0

SecondaryThrombosis

* 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.

Time frame:: Up until 24 hours after last dose of study drug
Reported as:: Number · participants

Thrombosis
participants	Desirudin
Thrombosis	8

Adverse events

Collected over up to 30 days after cessation of study drug. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Desirudin	—	80/516 (15.5%)	382/516 (74%)

Most frequent serious events

Showing 10 of 77

Most frequent serious events
Event	Desirudin
small intestinal obstructionGastrointestinal disorders	7/516
atrial fibrillationCardiac disorders	5/516
postoperative ileusInjury, poisoning and procedural complications	5/516
renal failure acuteRenal and urinary disorders	5/516
acute myocardial infarctionCardiac disorders	4/516
gastric hemorrhageGastrointestinal disorders	4/516
pleural effusionRespiratory, thoracic and mediastinal disorders	4/516
respiratory failureRespiratory, thoracic and mediastinal disorders	4/516
constipationGastrointestinal disorders	3/516
sepsisInfections and infestations	3/516

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Desirudin
constipationGastrointestinal disorders	76/516
nauseaGastrointestinal disorders	76/516
procedural painInjury, poisoning and procedural complications	59/516
anemiaBlood and lymphatic system disorders	45/516
breath sounds abnormalRespiratory, thoracic and mediastinal disorders	41/516
pyrexiaGeneral disorders	39/516
hypophosphataemiaMetabolism and nutrition disorders	38/516
tachycardiaCardiac disorders	37/516
astheniaGeneral disorders	36/516
anemia postoperativeInjury, poisoning and procedural complications	33/516

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Desirudin
<=18 years	0
Between 18 and 65 years	387
>=65 years	129

Age Continuous
Age Continuous(years)	Desirudin
Mean	59 ± 14.7

Sex: Female, Male
Sex: Female, Male(Participants)	Desirudin
Female	314
Male	202

Region of Enrollment
Region of Enrollment(participants)	Desirudin
United States	516

Study locations

16 sites

University of Colorado Health Science Center
Aurora, Colorado 80045, United States
University of South Florida, Tampa General Hospital
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

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2013, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: May 26, 2009
First posted: Jun 4, 2009
Start: Mar 2010
Primary completionActual: Jun 2011
CompletionActual: Jun 2011
Results first posted: Jan 3, 2013
Last update: Jan 10, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00913133
Lead sponsor: Canyon Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Jun 4, 2009
Start date: Mar 2010
Primary completion: Jun 2011
Completion: Jun 2011
Results posted: Jan 3, 2013
Last update: Jan 10, 2013

Study contacts

Dawn Bell, PharmD

study director · Canyon Pharmaceuticals, Inc.

Jerrold Levy, MD, FAHA

principal investigator · Emory University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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