Phase 4 N=8 Prevention

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

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02355743 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Development of CVAD Line Thrombosis — 0 thromboses

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rtPA lock therapy (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Lynn Malec
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Development of CVAD Line Thrombosis	—	—
SECONDARY Development of Line-associated Infection	0.5	—
SECONDARY Need for Central Line Replacement	1	—

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.

Eligibility Criteria

Inclusion Criteria

subjects with short bowel syndrome
requirement for central venous access device (CVAD) for long-term TPN administration
age >/= 6 months to 16 years at time of consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02355743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.