Clinical trial NCT00039858: Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Official title: Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombocytopenia
Thrombosis
Keywords: heparin-induced thrombocytopenia
heparin-induced thrombocytopenia and thrombosis
HIT
HITTS
anticoagulation
Lead sponsor: Encysive Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2002-06-14
Enrollment: 24
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital at UCLA
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Children's Hospital
state: Illinois
city: Peoria
country: United States
facility: Children's Hospital of Illinois
state: Illinois
city: Louisville
country: United States
facility: Kosair Children's Hospital, University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Congenital Heart Center
state: Michigan
city: Cleveland
country: United States
facility: Rainbow Babies at Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
References: