rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome

• Status: Completed
• Trial end date: 2016-09-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary research question is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lynn Malec; University of Pittsburgh
• Collaborator: University of Pittsburgh
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. subjects with short bowel syndrome

2. requirement for central venous access device (CVAD) for long-term TPN administration

3. age >/= 6 months to < 16 years

4. ability to initiate rtPA during hospitalization for newly inserted CVAD

5. ability to be enrolled within 48 hours of CVAD placement.

Exclusion Criteria:

1. platelet count <50,000

2. active bleeding

3. age =/> 16 years at time of consent.