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

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. Identifier: NCT00265005
Recruitment Status : Terminated (difficulty in recruiting subjects)
First Posted : December 13, 2005
Last Update Posted : April 4, 2018
Genentech, Inc.
Information provided by (Responsible Party):
Janice E. Sullivan, University of Louisville

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: alteplase Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Ranging, Safety And Efficacy Of Cathflo(TM) Activase(R) (Alteplase) For The Treatment Of Central Catheter Occlusion In Neonates And Infants; Phase I
Study Start Date : June 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: All
All subjects receive active drug up to a total of 3 doses
Drug: alteplase
Iv administration of 1 mg/ml up to two times and 2 mg/ml if needed.
Other Name: Cathflo Activase

Primary Outcome Measures :
  1. Restoration of central access device patency following one, two or three instillations of t-PA. [ Time Frame: within 180 minutes of administering the study drug ]

Secondary Outcome Measures :
  1. Restoration of patency following instillation of 1 mg/mL (i.e., first instillation) [ Time Frame: within 60 minutes from the first instillation of study drug ]
  2. Restoration of patency following instillation of 1 mg/mL (i.e., second instillation) [ Time Frame: within 60 minutes from the second instillation of study drug ]
  3. Restoration of patency following instillation of 2 mg/mL (i.e., third instillation) [ Time Frame: within 60 minutes from the third instillation of study drug ]
  4. The following safety outcome measure will be evaluated: • Major bleeding complications • Sepsis • Embolic events • All serious adverse events [ Time Frame: Within 14 days of study drug administration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   28 Weeks to 66 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00265005

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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Genentech, Inc.
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Principal Investigator: Janice E Sullivan, MD University of Louisville
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Responsible Party: Janice E. Sullivan, Professor, University of Louisville Identifier: NCT00265005    
Other Study ID Numbers: tPA 255-04
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: December 2015
Keywords provided by Janice E. Sullivan, University of Louisville:
occluded central venous catheter
occluded arterial catheter
occluded PICC
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action