Phase 4
Completed N=8
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome
Short Bowel Syndrome
Source: ClinicalTrials.gov NCT02355743 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Development of CVAD Line Thrombosis — 0 thromboses
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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.
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. Informational only — not medical advice.