Investigations into a TNF inhibitor to limit complications following complex surgery

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000001392

Enrollment

Registered

2008-01-07

Start date

2008-04-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will assess if a TNF inhibitor is safe to administer to patients undergoing vascular surgery. If so we will commence further trials to assess if a TNF inhibitor improves clinical outcomes.

Interventions

A intravenous (IV) TNF inhibitor. A single 100 ml dose of TNF inhibitor administered IV over 30 minutes, just prior to surgery. The control treatment is standard care. The follow up period will be 90 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Scheduled for elective vascular surgery

Exclusion criteria

concurrent use of Interleukin-1 antagonist, septic arthritis in last 12 months, any infection, pregnancy

Outcome results