Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ARCA Biopharma, Inc.
Further study details as provided by Nuvelo
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must give written informed consent
Ages 18 or older
Unable to withdraw at least 3 mL of blood from a central venous access device
Hemodynamically stable
Available for follow-up assessments
You may not be if
Inability to infuse at least 2 mL of saline through the catheter
Catheter placed less than 48 hours prior to detection of occlusion
Catheter used for hemodialysis or pheresis
Previous treatment with plasminogen activator for current episode of catheter occlusion
Less than 18 years of age
Any evidence of mechanical or nonthrombotic occlusion
In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
Increased risk for drug extravasation
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)
Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
Any other subject feature that in the opinion of the investigator should preclude study participation
Clareo Health | Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
