Study Of Angiomax In Infants Under Six Months With Thrombosis

Brief Summary

Official Title: “Pilot Dose Finding And Efficacy Study Of Angiomax┬« (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis”

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;

2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Detailed Clinical Trial Description

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;

2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Interventions Used in this Clinical Trial

  • Drug: Angiomax (bivalirudin)

Outcome Measures for this Clinical Trial

Primary Measures

  • Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary Measures

  • In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
  • Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
  • Age less than 6 months .
  • Gestational age greater than 35 weeks
  • Expected life expectancy at least 14 days.
  • No contraindication to anticoagulation i.e. bleeding complications.

Exclusion Criteria

  • Active or recent (less than 7 days) bleeding.
  • Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
  • Refusal to undergo blood transfusion should it become necessary.
  • 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.
  • Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
  • Platelet count < 50,000 cells/mm3
  • Birth Trauma
  • Planned or indicated surgery within 30 days
  • Major or minor bleeding event

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 6 Months

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • The Medicines Company
  • Overall Official(s)
    • Guy Young, MD, Principal Investigator, Children’s Hospital Orange County

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00043277