TRIST
Trial question
Is restrictive RBC transfusion strategy noninferior to liberal RBC transfusion strategy in patients undergoing hematopoietic cell transplantation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 299
299 patients (108 female, 191 male).
Inclusion criteria: patients with hematologic malignancies requiring hematopoietic cell transplantation.
Key exclusion criteria: pregnancy or lactation; receipt of RBC transfusion after hematopoietic cell transplantation before enrollment; or receipt of hematopoietic cell transplantation for nonmalignant diseases.
Interventions
N=149 restrictive strategy (hemoglobin threshold < 70 g/L).
N=150 liberal strategy (hemoglobin threshold < 90 g/L).
Primary outcome
Health-related quality of life measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplantation score at day 100
112.8 points
107.5 points
112.8 points
84.6 points
56.4 points
28.2 points
0.0 points
Restrictive
strategy
Liberal
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in health-related QoL measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplantation score at day 100 (112.8 points vs. 107.5 points; AD 1.6 points, 95% CI -2.5 to 5.6).
Secondary outcomes
No significant difference in transplantation-related deaths at day 100 (1.34% vs. 2.67%; RR 0.5, 95% CI 0.09 to 2.71).
No significant difference in sinusoidal obstruction syndrome (5.71% vs. 5.56%; RR 1.03, 95% CI 0.27 to 3.95).
No significant difference in acute graft versus host disease (31.75% vs. 39.71%; RR 0.8, 95% CI 0.5 to 1.27).
Safety outcomes
No significant difference in transfusion-related adverse events.
Significant difference in RBC unit transfusions (2.73 units vs. 5.02 units).
Conclusion
In patients with hematologic malignancies requiring hematopoietic cell transplantation, restrictive strategy was noninferior to liberal strategy with respect to a health-related QoL measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplantation score at day 100.
Reference
Jason Tay, David S Allan, Elizabeth Chatelain et al. Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial. J Clin Oncol. 2020 May 1;38(13):1463-1473.
Open reference URL