This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
TRISS was a phase 3 randomized, parallel-design clinical trial evaluating SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion in patients with septic shock.
| Feature | TRISS |
|---|---|
| Condition | Septic Shock |
| Status | COMPLETED |
| Start date | 2011-11 |
| Primary completion date | 2014-03 |
| Allocation | RANDOMIZED |
| Design model | PARALLEL |
| Masking | SINGLE |
| Primary purpose | TREATMENT |
| Lead sponsor | Scandinavian Critical Care Trials Group |
2. Clinical Question
Population
Patients with septic shock enrolled in a randomized phase 3 transfusion trial.
Intervention
SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion.
Comparator
The registry lists two SAGM blood transfusion intervention descriptions.
Primary question
The trial evaluated all cause 90 day mortality.
3. Trial Design
1005 participants
Parallel randomized design
SAGM blood transfusion
90 day mortality
4. Endpoints
| Endpoint | Definition | Time frame |
|---|---|---|
| Mortality | All cause 90 day mortality | 90 day |
5. Planned Analysis
The registry identifies mortality as the primary endpoint but does not contain posted statistical analyses or reported endpoint estimates.
For a randomized trial with a time-defined mortality endpoint, statistical analysis would typically compare mortality outcomes between randomized groups using methods appropriate for binary survival outcomes or time-to-event outcomes, depending on the prespecified statistical analysis plan.
6. Statistical Methodology
The statistical framework of TRISS is based on randomized treatment comparison. Randomization is intended to balance known and unknown prognostic factors between groups, allowing differences in outcomes to be interpreted as comparisons between assigned strategies.
Mortality endpoints
Mortality is a clinical endpoint where each participant contributes an outcome status over a defined follow-up period. Analysis commonly focuses on the difference between randomized groups while accounting for the prespecified endpoint definition and follow-up window.
7. Statistical Methods Explained
Why is randomization important?
Randomization creates comparable groups at baseline and reduces confounding from measured and unmeasured factors.
Why define a 90 day mortality endpoint?
A fixed follow-up window gives the comparison a clearly specified time horizon and avoids ambiguity about when outcomes are evaluated.
How are mortality endpoints commonly analyzed?
Depending on the analysis plan, investigators may compare proportions experiencing death by the endpoint time or model time to death using survival methods.
Why is the analysis plan important?
The prespecified statistical analysis determines how outcomes are compared, how uncertainty is quantified, and how conclusions are interpreted.
8. Limitations
- No posted statistical analyses: The registry does not report effect estimates, confidence intervals, or p-values.
- Endpoint interpretation: Mortality results require the exact analysis population and statistical plan for complete interpretation.
- Trial design details: Additional methodological details such as stratification, multiplicity adjustments, interim analyses, and missing-data procedures are not reported in the registry information used here.
9. Why This Trial Matters Statistically
| Concept | How it appears in TRISS |
|---|---|
| Randomization | Randomized phase 3 comparison |
| Parallel design | Two-arm parallel trial structure |
| Clinical endpoint | All cause 90 day mortality |
| Statistical inference | Requires comparison between randomized groups with uncertainty estimates |
10. Related Tutorials
Learn more about the methods used in this trial:
11. Related Calculators
12. Sources
- ClinicalTrials.gov record: TRISS (NCT01485315)