Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to … (NCT00039858) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
United States24 participantsStarted 2003-09
Plain-language summary
The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
Who can participate
Age range16 Years
SexALL
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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 c…