TerminatedPhase 3

Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

Stopped: very slow accrual.

Canada28 participantsStarted 2012-03

Plain-language summary

The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
✓. Drain(s) must be inserted within the 23hrs prior to enrollment in the study.

Exclusion criteria

✕. Patients and parents must have signed informed consent to participate in the study.
✕. Pancreatic abscess (not bacterial in nature)
✕. Known coagulation impairment
✕. Known central nervous system tumor or abscesses
✕. Arteriovenous malformation
✕. Aneurysm or history of central nervous system bleeding
✕. Hypersensitivity to tPA
✕. Recent administration of an investigational drug (within previous 30 days)

What they're measuring

Length of time the drain remains insitu

Timeframe: up to 2 weeks

Trial details

NCT IDNCT01576679

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Intra-abdominal Abscess trials