Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if alteplase is effective in dissolving a clot in a catheter in a large vein (central venous line or PICC line) or artery in infants less than 6 months of age.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: Genentech, Inc.
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Ability to provide written informed consent by the parent or legal guardian and comply with study assessments for the full duration of the study

• Hospitalized premature neonates (28- < 34 weeks CGA), term neonates (34 weeks-< 40 weeks CGA) and infants (> = 40 weeks to 6 months CGA).

• Presence of central access device. All types of permanent and temporary catheters are eligible [e.g., central venous catheter (CVC), peripherally-inserted central catheter (PICC), umbilical arterial catheter (UAC), or umbilical venous catheter (UVC)] except hemodialysis catheters. The catheter must be properly inserted as evidenced by the ability to have used the catheter at least once for its intended purpose (i.e., to withdraw blood and/or infuse fluids)and documentation correct catheter placement radiographically within 48 hours of the catheter becoming non-patent.

• Partial or total occlusion of at least one lumen of the catheter

Exclusion Criteria:

• CGA > 66 weeks

• Incorrect catheter placement or evidence of mechanical occlusion

• Occlusion due to suspected drug precipitate

• Active internal bleeding, involving intracranial or retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts

• Recent history (i.e., < 6 months) of intraventricular hemorrhage (IVH) or other active intracranial process that could predispose to intracranial bleeding

• Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention

• Any of the following known or suspected hemorrhagic events within the preceding 7 days or any other significant bleeding risk:

• Gastrointestinal bleeding

• Intra-ocular surgery

• Any of the following known events or suspected hemorrhagic events within the preceding 48 hours

• Major surgery (excluding central line placement)

• Organ biopsy

• Major trauma

• Puncture of a non-compressible vessel within the previous 48 hours

• Treatment with indomethacin within the previous 48 hours

• Received any fibrinolytic agent within 24 hours of enrollment

• Known risk for embolization, including history of left heart thrombus, mitral mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis

• Known hypersensitivity to alteplase or any component in the formulation of CathfloTM Activase®

• Prior enrollment in the current study

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated or the patient has a known condition for which bleeding constitutes a significant hazard

• Participation in another simultaneous interventional medical investigation or trial

• Documented or suspected catheter infection

• Thrombocytopenia (i.e. platelet count < 20,000)