CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
rtPA lock therapydrug
Likely dose
rtPA lock therapy 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02355743
NCT02355743Phase 4Completed
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Prophylactic Recombinant Tissue Plasminogen Activator in the Prevention of Central Venous Access Device (CVAD)-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome

Lynn Malec·interventional·Posted Feb 4, 2015·Updated Feb 6, 2018

In Brief

A Phase 4 clinical trial evaluating rtPA lock therapy for Short Bowel Syndrome. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesUnited States
CollaboratorsUniversity of Pittsburgh

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 4, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 3, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.4 years ago

Interventions

rtPA lock therapydrug

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as "lock therapy" in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.