Primary and secondary outcomes
| Outcome . | ITT . | PP . | ||
|---|---|---|---|---|
| HEM . | HSM . | HEM . | HSM . | |
| PCI at 1 h (range, 10-90 min) posttransfusion | ||||
| N of evaluable transfusions | 107 | 112 | 105 | 108 |
| Mean (SD)* | 23.9 (15) | 23.5 (14.1) | 23.8 (15.2) | 24.0 (14.1) |
| Mean difference (95% CI)† | −0.1 (95% CI, −2.9 to 2.8) | −0.5 (95% CI, −3.4 to 2.4) | ||
| P† | .9686 | .7469 | ||
| PCI at 24 h (range, 8-36 h) posttransfusion | ||||
| N of evaluable transfusions | 94 | 101 | 94 | 97 |
| Mean (SD)* | 12.2 (11.9) | 12 (12.6) | 12.2 (11.9) | 12.2 (12.8) |
| Mean difference (95% CI)† | 0.1 (95% CI, −2.3 to 2.5) | 0.0 (95% CI, −2.4 to 2.4) | ||
| P† | .9193 | .9872 | ||
| CCI at 1 h (range, 10-90 min) posttransfusion | ||||
| N of evaluable transfusions | 107 | 112 | 105 | 108 |
| Mean (SD)* | 17.7 (11.0) | 17.5 (10.2) | 17.7 (11.1) | 17.8 (10.2) |
| Mean difference (95% CI)† | 0.1 (95% CI, −2.0 to 2.1) | −0.3 (95% CI, −2.3 to 1.8) | ||
| P† | .9468 | .8014 | ||
| CCI at 24 h (range, 8-36 h) posttransfusion | ||||
| N of evaluable transfusions | 94 | 101 | 94 | 97 |
| Mean (SD)* | 9.1 (8.7) | 9.0 (9.4) | 9.1 (8.7) | 9.2 (9.5) |
| Mean difference (95% CI)† | 0 (95% CI, −1.8 to 1.7) | −0.1 (95% CI, −1.9 to 1.6) | ||
| P† | .9804 | .8850 | ||
| Clinically assessed bleeding score pretransfusion | ||||
| Total n of transfusions with score of: | 151 | 149 | 148 | 146 |
| 0 | 99 | 85 | 96 | 83 |
| 1 | 29 | 37 | 29 | 36 |
| 2 | 23 | 26 | 23 | 26 |
| 3 | 0 | 1 | 0 | 1 |
| 4 | 0 | 0 | 0 | 0 |
| N of transfusions with score >0 | 52 | 64 | 52 | 63 |
| OR of bleeding score >0 (95% CI)†‡ | 0.74 (95% CI, 0.42-1.30) | 1 | 0.79 (95% CI, 0.45-1.41) | 1 |
| P†‡ | .2920 | .4245 | ||
| Participant self-assessed score 3 d posttransfusion or until next platelet transfusion, whichever occurred first | ||||
| N of participants with ≥1 score | 34 | 31 | 34 | 30 |
| Total n of transfusions with ≥1 score, maximum score of: | 93 | 106 | 91 | 103 |
| 0 | 64 | 71 | 64 | 68 |
| 1 | 11 | 19 | 10 | 19 |
| 2 | 17 | 16 | 16 | 16 |
| 3 | 1 | 0 | 1 | 0 |
| 4 | 0 | 0 | 0 | 0 |
| N of transfusions with maximum score >0 | 29 | 35 | 27 | 35 |
| OR of bleeding score >0 (95% CI)†§ | 0.94 (95% CI, 0.47-1.90) | 1 | 0.84 (95% CI, 0.42-1.71) | 1 |
| P†§ | .8653 | .6355 | ||
| Interval between trial platelet transfusions during treatment period | ||||
| N of participants with ≥1 interval, ≤14 d in duration | 41 | 39 | 40 | 38 |
| Overall mean (SD), h*‖ | 94.0 (62.8) | 97.3 (58.0) | 96.3 (62.3) | 99.8 (57.7) |
| Treatment effect (95% CI)¶# | 0.95 (95% CI, 0.78-1.15) | 0.96 (95% CI, 0.78-1.17) | ||
| P¶ | .5782 | .6634 | ||
| Outcome . | ITT . | PP . | ||
|---|---|---|---|---|
| HEM . | HSM . | HEM . | HSM . | |
| PCI at 1 h (range, 10-90 min) posttransfusion | ||||
| N of evaluable transfusions | 107 | 112 | 105 | 108 |
| Mean (SD)* | 23.9 (15) | 23.5 (14.1) | 23.8 (15.2) | 24.0 (14.1) |
| Mean difference (95% CI)† | −0.1 (95% CI, −2.9 to 2.8) | −0.5 (95% CI, −3.4 to 2.4) | ||
| P† | .9686 | .7469 | ||
| PCI at 24 h (range, 8-36 h) posttransfusion | ||||
| N of evaluable transfusions | 94 | 101 | 94 | 97 |
| Mean (SD)* | 12.2 (11.9) | 12 (12.6) | 12.2 (11.9) | 12.2 (12.8) |
| Mean difference (95% CI)† | 0.1 (95% CI, −2.3 to 2.5) | 0.0 (95% CI, −2.4 to 2.4) | ||
| P† | .9193 | .9872 | ||
| CCI at 1 h (range, 10-90 min) posttransfusion | ||||
| N of evaluable transfusions | 107 | 112 | 105 | 108 |
| Mean (SD)* | 17.7 (11.0) | 17.5 (10.2) | 17.7 (11.1) | 17.8 (10.2) |
| Mean difference (95% CI)† | 0.1 (95% CI, −2.0 to 2.1) | −0.3 (95% CI, −2.3 to 1.8) | ||
| P† | .9468 | .8014 | ||
| CCI at 24 h (range, 8-36 h) posttransfusion | ||||
| N of evaluable transfusions | 94 | 101 | 94 | 97 |
| Mean (SD)* | 9.1 (8.7) | 9.0 (9.4) | 9.1 (8.7) | 9.2 (9.5) |
| Mean difference (95% CI)† | 0 (95% CI, −1.8 to 1.7) | −0.1 (95% CI, −1.9 to 1.6) | ||
| P† | .9804 | .8850 | ||
| Clinically assessed bleeding score pretransfusion | ||||
| Total n of transfusions with score of: | 151 | 149 | 148 | 146 |
| 0 | 99 | 85 | 96 | 83 |
| 1 | 29 | 37 | 29 | 36 |
| 2 | 23 | 26 | 23 | 26 |
| 3 | 0 | 1 | 0 | 1 |
| 4 | 0 | 0 | 0 | 0 |
| N of transfusions with score >0 | 52 | 64 | 52 | 63 |
| OR of bleeding score >0 (95% CI)†‡ | 0.74 (95% CI, 0.42-1.30) | 1 | 0.79 (95% CI, 0.45-1.41) | 1 |
| P†‡ | .2920 | .4245 | ||
| Participant self-assessed score 3 d posttransfusion or until next platelet transfusion, whichever occurred first | ||||
| N of participants with ≥1 score | 34 | 31 | 34 | 30 |
| Total n of transfusions with ≥1 score, maximum score of: | 93 | 106 | 91 | 103 |
| 0 | 64 | 71 | 64 | 68 |
| 1 | 11 | 19 | 10 | 19 |
| 2 | 17 | 16 | 16 | 16 |
| 3 | 1 | 0 | 1 | 0 |
| 4 | 0 | 0 | 0 | 0 |
| N of transfusions with maximum score >0 | 29 | 35 | 27 | 35 |
| OR of bleeding score >0 (95% CI)†§ | 0.94 (95% CI, 0.47-1.90) | 1 | 0.84 (95% CI, 0.42-1.71) | 1 |
| P†§ | .8653 | .6355 | ||
| Interval between trial platelet transfusions during treatment period | ||||
| N of participants with ≥1 interval, ≤14 d in duration | 41 | 39 | 40 | 38 |
| Overall mean (SD), h*‖ | 94.0 (62.8) | 97.3 (58.0) | 96.3 (62.3) | 99.8 (57.7) |
| Treatment effect (95% CI)¶# | 0.95 (95% CI, 0.78-1.15) | 0.96 (95% CI, 0.78-1.17) | ||
| P¶ | .5782 | .6634 | ||
OR, odds ratio.
Unadjusted.
Adjusted for pretransfusion platelet count, period effect, and random participant effect.
Excludes 4 transfusions where pretransfusion platelet count was not reported.
Excludes 2 transfusions where pretransfusion platelet count was not reported.
Mean interval for each participant/treatment type was first calculated, and using these, an overall mean for each treatment type is presented. Only intervals ≤14 d in duration were included.
Adjusted for random participant effect.
Adjusted ratio of geometric means of interval from HSM over HEM and corresponding 95% CIs are reported.