Safety and efficacy of artesunate treatment in severely injured patients with traumatic hemorrhage. The TOP-ART randomized clinical trial
- terminated early for safety concerns
- Terminated after enrolment of 90 of a target 105 patients because of safety concerns
Authors' conclusion
Among critically ill trauma patients, artesunate is unlikely to improve organ dysfunction and might be associated with a higher VTE rate.
Study context
- Population
- Adult trauma patients activating the major hemorrhage protocol at a London major trauma center75 per-protocol
- Participants
- 90 patients
- Comparison
- IV artesunate bolus vs placebo within 4 h of injury
- Artesunaten = 54
- Placebon = 29reference
- Primary endpoint
- Sequential organ failure assessment (SOFA) score (primary efficacy outcome)
- Follow-up
- 48 h
Methodological detailsblinded, placebo-controlled, phase IIa, single-centre, Artesunate participants more shocked at admission (median base deficit 9 vs 4.7, p = 0.042)
- Blinded
- Placebo-controlled
- Phase IIa
- Single-centre
- Artesunate participants more shocked at admission (median base deficit 9 vs 4.7, p = 0.042)
Primary result
As reported in the abstract
SOFA score
Artesunate
5.5
median
Placebo
4
median
P = 0.303
Secondary outcomes
- Superiority of artesunate not supported by any secondary endpoint
Safety
SAEs · 28 days
VTE
- Serious adverse event (SAEs): safety population n = 83
Original publication
Safety and efficacy of artesunate treatment in severely injured patients with traumatic hemorrhage. The TOP-ART randomized clinical trial. Intensive Care Med. Published 20 July 2023. doi:10.
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