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

NCT00265005 | Terminated Phase 1 DMC

• 1 other identifier: tPA 255-04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Keywords

alteplase; occluded central venous catheter; occluded arterial catheter; occluded PICC; neonates; infants

Outcome Measures

Primary Outcomes (1)

• Restoration of central access device patency following one, two or three instillations of t-PA.

  within 180 minutes of administering the study drug

Secondary Outcomes (4)

• Restoration of patency following instillation of 1 mg/mL (i.e., first instillation)

  within 60 minutes from the first instillation of study drug

• Restoration of patency following instillation of 1 mg/mL (i.e., second instillation)

  within 60 minutes from the second instillation of study drug

• Restoration of patency following instillation of 2 mg/mL (i.e., third instillation)

  within 60 minutes from the third instillation of study drug

• The following safety outcome measure will be evaluated: • Major bleeding complications • Sepsis • Embolic events • All serious adverse events

  Within 14 days of study drug administration

Study Arms (1)

All

EXPERIMENTAL

All subjects receive active drug up to a total of 3 doses

Drug: alteplase

Interventions

alteplase DRUG

Iv administration of 1 mg/ml up to two times and 2 mg/ml if needed.

Also known as: Cathflo Activase

All

Eligibility Criteria

• Age: 28 Weeks - 66 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Janice E Sullivan, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2012
• Last Updated: April 4, 2018

Record last verified: 2015-12

Locations

US (1)