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

Completed · Phase 4

Conditions studied: Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02355743

Run by

Lynn Malec

People needed

8

Starts

2015-02-01

Expected to finish

2016-09-03

Last updated by the study team

2018-02-06

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• subjects with short bowel syndrome
• requirement for central venous access device (CVAD) for long-term TPN administration
• age >/= 6 months to < 16 years
• ability to initiate rtPA during hospitalization for newly inserted CVAD
• ability to be enrolled within 48 hours of CVAD placement.

You may not qualify if…

• platelet count <50,000
• active bleeding
• age =/> 16 years at time of consent.

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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