Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265005
Status:
TERMINATED
Last Update Posted:
2018-04-04
First Post:
2005-12-12
Brief Title:
Safety and Efficacy of Tissue Plasminogen Activator tPA in Neonates and Infants
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Dose-Ranging Safety And Efficacy Of CathfloTM ActivaseR Alteplase For The Treatment Of Central Catheter Occlusion In Neonates And Infants Phase I
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty in recruiting subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Hospitalized patients with central access devices will be screened Ninety subjects with at least one occluded lumen of a central access device will be eligible Thirty subjects will be enrolled in each of the following age groups 28-34 weeks CGA 34- 40 weeks CGA and 40 weeks to 66 weeks CGA
Inclusion Criteria
Subjects will be eligible if the following criteria are met
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 34-40 weeks CGA and infants 40 weeks to 66 weeks CGA
Presence of a central access device All types of permanent and temporary catheters are eligible eg 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 ie to withdraw blood andor infuse fluids and documentation of 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
Subjects who meet any of the following criteria will be excluded from this study
CGA 66 weeks
Incorrect catheter placement see section 31 or evidence of mechanical occlusion
By clinical examination there is evidence that the catheter has migrated or become dislodged This is determined by confirming the depth to which the catheter had been positioned on insertion or adjusted to after placement
There is evidence of mechanical obstruction of the catheter on the portion is any that is visible from the catheter hub to the skin insertion site eg kinking or twisting of the catheter
Occlusion due to suspected drug precipitate in the opinion of the investigator
Active internal bleeding involving intracranial and retroperitoneal sites or the gastrointestinal genitourinary or respiratory tracts
Recent history ie 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 eg 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 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 interventional investigation or trial within the previous 30 days
Documented or suspected catheter infection
Thrombocytopenia ie platelet count 20000
METHOD OF TREATMENT ASSIGNMENT This is an open-label study and all subjects will receive CathfloTM Activase
Inclusion Criteria
Subjects will be eligible if the following criteria are met
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 34-40 weeks CGA and infants 40 weeks to 66 weeks CGA
Presence of a central access device All types of permanent and temporary catheters are eligible eg 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 ie to withdraw blood andor infuse fluids and documentation of 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
Subjects who meet any of the following criteria will be excluded from this study
CGA 66 weeks
Incorrect catheter placement see section 31 or evidence of mechanical occlusion
By clinical examination there is evidence that the catheter has migrated or become dislodged This is determined by confirming the depth to which the catheter had been positioned on insertion or adjusted to after placement
There is evidence of mechanical obstruction of the catheter on the portion is any that is visible from the catheter hub to the skin insertion site eg kinking or twisting of the catheter
Occlusion due to suspected drug precipitate in the opinion of the investigator
Active internal bleeding involving intracranial and retroperitoneal sites or the gastrointestinal genitourinary or respiratory tracts
Recent history ie 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 eg 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 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 interventional investigation or trial within the previous 30 days
Documented or suspected catheter infection
Thrombocytopenia ie platelet count 20000
METHOD OF TREATMENT ASSIGNMENT This is an open-label study and all subjects will receive CathfloTM Activase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None