Respiratory failure & ventilation
Alteplase in COVID-19 severe hypoxemic respiratory failure: the TRISTARDS multicenter randomized trial
Authors' conclusion
Alteplase was not associated with faster clinical recovery from COVID-19 severe hypoxemic respiratory failure.
Study context
- Population
- Patients with COVID-19 severe hypoxemic respiratory failure65% on HFNO or NIV at baseline
- Participants
- 69 vs 35
- Comparison
- Alteplase over 5 days plus standard of care (SOC) vs SOC alone
- Alteplasen = 69
- SOCn = 35reference
- Primary endpoint
- Time to clinical improvement (≥ 2-point decrease on WHO Clinical Progression Scale, or hospital discharge)
- Follow-up
- Up to Day 28
Methodological detailsmulticentre, open-label, closed early (insufficient recruitment), Study closed early due to insufficient patient recruitment
- Multicentre
- Open-label
- Closed early (insufficient recruitment)
- Study closed early due to insufficient patient recruitment
Primary result
As reported in the abstract
Median time to clinical improvement
| Group | Value | Note |
|---|---|---|
| Alteplase | median 25 days | |
| SOC | median > 28 days | median not reached |
Value
Alteplasemedian 25 days
SOCmedian > 28 days
Note
Alteplase— not stated in the abstract
SOCmedian not reached
Secondary outcomes
All-cause mortality · up to Day 28
unadjusted risk difference - 17% (- 34 to 0) · P = 0.047
| Outcome | Alteplase | SOC | Adjusted RD (95% CI) | P value |
|---|---|---|---|---|
| All-cause mortality · up to Day 28 | - 16% (- 31 to 1) | P = 0.058 | ||
| Change in PaO2/FiO2 ratio vs baseline · Day 6 | mean + 30 (SD 84) mmHg | mean - 12 (SD 59) mmHg | P = 0.052 |
Subgroups (high-dose alteplase; no invasive ventilation)
- Differences greater with high-dose alteplase and in patients not receiving invasive ventilation
Safety
| Outcome | Alteplase | SOC |
|---|---|---|
| Treatment discontinuation due to AEs | 26.1% | — not stated in the abstract |
| Major bleeding | 9 events | 0 events |
— not stated in the abstract
Major bleeding
- No bleeding was fatal
Original publication
Alteplase in COVID-19 severe hypoxemic respiratory failure: the TRISTARDS multicenter randomized trial. Ann Intensive Care. Published 10 November 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →