Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00039858 |
Recruitment Status :
Completed
First Posted : June 14, 2002
Last Update Posted : January 11, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thrombocytopenia Thrombosis | Drug: Argatroban | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin |
Study Start Date : | September 2003 |
Study Completion Date : | March 2006 |


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Ages Eligible for Study: | up to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria for Inclusion:
- Males and females ages birth to 16 years,inclusive, at enrollment. For neonates, the minimum corrected gestational age should be 37 weeks.
- Documented HIT defined as a fall in platelet count to less than 100,000/uL or a >=50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT, or
- Require anticoagulation and have a documented history of a positive HIT test in the absence of current thrombocytopenia (i.e. patients at risk for HIT), or
- In the opinion of the investigator, require alternative anticoagulation due to an underlying condition, such as AT-III deficiency or heparin resistance.
- Signed (written) informed consent or assent by the patient (if age appropriate) and the patient's parent or guardian.
Criteria for Exclusion:
- Any condition which, in the investigator's opinion, would contraindicate the use of Argatroban or would endanger the patient if he/she participated in this trial.
- Unexplained aPTT > 2 times the upper limit of normal at baseline, in the absence of heparin.
- International Normalized Ratio (INR) >1.6 at baseline in the absence of warfarin.
- Known clinical site of bleeding or predisposition to bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA,retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion. Patients who have a known clinical site of bleeding may be enrolled if the investigator deems the risk of continued thrombosis to outweigh the potential bleeding risk.
- Any patient who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than Argatroban during the course of the study.
- Known hypersensitivity to Argatroban or chemically related compounds.
- Females of childbearing potential who are pregnant (positive serum beta-HCG), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. IUD or oral contraceptives).
- Any patient receiving a thrombolytic medication (e.g. tPA).
- Any neonate with a corrected gestational age of < or = 44 weeks and bleeding in the head (Grade I or above) as determined by head ultrasound.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039858
United States, California | |
Mattel Children's Hospital at UCLA | |
Los Angeles, California, United States, 90095 | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
University of Chicago Children's Hospital | |
Chicago, Illinois, United States, 60637 | |
Children's Hospital of Illinois | |
Peoria, Illinois, United States, 61614 | |
United States, Kentucky | |
Kosair Children's Hospital, University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Children's Hospital of Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Michigan Congenital Heart Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Ohio | |
Rainbow Babies at Children's Hospital | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97201 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Utah | |
Primary Children's Medical Center | |
Salt Lake City, Utah, United States, 84113 | |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 |
ClinicalTrials.gov Identifier: | NCT00039858 |
Other Study ID Numbers: |
ARG-401 SKF105043/013 |
First Posted: | June 14, 2002 Key Record Dates |
Last Update Posted: | January 11, 2007 |
Last Verified: | January 2007 |
heparin-induced thrombocytopenia heparin-induced thrombocytopenia and thrombosis HIT HITTS anticoagulation |
Thrombosis Thrombocytopenia Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Blood Platelet Disorders Hematologic Diseases Argatroban |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Platelet Aggregation Inhibitors |