Central venous access device withdrawl occlusion MedDRA version: 9.1 Level: LLT Classification code 10051149 Term: Catheter occlusion
Conditions
Interventions
Product Name: Alfimeprase
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Alfimeprase
CAS Number: 259074-76-5
Other descriptive name: 3-203 Fibrolase [3-Ser] (A
Sponsors
Nuvelo, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be elligible for enrollment: a) The subject (or legally authorized representative) must give written informed consent. b) Unable to withdraw 3 mL of blood from a central venous access device. c) Hemodynamically stable (i.e. no need for intravenous fluids and/or pressors to maintain blood pressure and/or urine output). d) Available for follow-up assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not eligible for enrollment: a) Inability to infuse at least 2 mL of saline through the catheter. b) Catheter placed <48 hours prior to detection of occlusion. c) Catheter used for hemodialysis or pheresis. d) Plasminogen activator (e.g. Cathflo Activase) used to treat the current episode of catheter occlusion. e) <18 years of age. f) Any evidence of mechanical or nonthrombic occlusion (prior to subject enrollment, the withdrawl occlusion should be confirmed after repositioning of the subject and asking the subject to move his/her extremities, cough and perform the Valsalva maneuver to minimize the chance that the occlusion is due to mechanical or nonthrombic causes. The investigator may also consider X-ray to radiographically visualise the occluded catheter to rule out obvious mechanical occlusion). g) In the opinion of the investigator, the subject is at "high risk" for bleeding events or embolic complications, or has a condition for which bleeding constitutes a significant hazard. h) Increased risk for drug extravasation. i) Pregnant, lactating, or actively menstruating women and women of child bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator). j) Known right-to-left cardiac shunt, patent foramen ovale, or atriallventricular septal defect. k) Participation in any other study of an investigational device, medication, biologic or other agent within the 30 days before enrollment and until the 30 day follow-up visit. l) Any other subject feature that in the opinion of the investigator should preclude study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of alfimeprase.;Secondary Objective: To evaluate the efficacy of alfimeprase measured by: The proportion of subjects with re-establishment of a functional CVAD 15 minutes following the instillation of study drug. The proportion of subjects with re-establishment of a functional CVAD 30 minutes following the instillation of study drug. The proportion of subjects with re-establishment of a functional CVAD 60 minutes following the instillation of study drug.;Primary end point(s): Primary Endpoint: The rates of adverse events, serious adverse events and major bleeding events during the time from instillation of the study drug until up to 120 minutes following the instillation of study drug. Secondary Endpoints: The proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the instillation of study drug. The proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the instillation of study drug. The proportion of subjects with re-establishment of a functional central venous access device 60 minutes following the instillation of study drug. | — |
Countries
Belgium, Czech Republic, Germany
Outcome results
None listed