Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants - Full Text View

Sponsor:	University of Louisville
Collaborator:	Genentech
Information provided by (Responsible Party):	University of Louisville
ClinicalTrials.gov Identifier:	NCT00265005

Purpose

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	Intervention	Phase
Thrombosis	Drug: alteplase	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2012
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility

Ages Eligible for Study:	28 Weeks to 66 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265005

Locations

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Genentech

Investigators

Principal Investigator:

Janice E Sullivan, MD

University of Louisville

More Information

Additional Information:

Department of Pediatrics webpage for Kosair Charities Pediatric Clinical Research Unit This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00265005 History of Changes
Other Study ID Numbers:	tPA 255-04
Study First Received:	December 12, 2005
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Louisville:

alteplase
occluded central venous catheter
occluded arterial catheter

occluded PICC
neonates
infants

Additional relevant MeSH terms:

Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012