Summary of efficacy measurements
| Variable | Study group (n=43) | Control group (n=43) | P values |
| Composite endpoint (clinical haemostasis+endoscopic haemostasis*), no. (%)† | 38/43 (88) (95% CI 87.52 to 88.48) | 27/43 (63) (95% CI 61.94 to 64.06) | 0.0057 |
| Clinical haemostasis, no. (%) | 38 (88) (95% CI 87.52 to 88.48) | 30 (70) (95% CI 69.04 to 70.96) | 0.034 |
| Haemostasis after Hemospray application at 2 hours endoscopy, no. (%) | 39 (91) (95% CI 90.63 to 91.37) | NA | NA |
| Endoscopic haemostasis at 12 hours endoscopy*, no. (%)† | 38/38 (100) | 27/30 (90) (95% CI 89.41 to 90.59) | 0.0466 |
| Treatment failure at 5 days, no. (%)‡ | 5 (12) (95% CI 11.52 to 12.48) | 16 (38) (95% CI 36.93 to 39.07) | 0.006 |
| Death within 5 days, no. (%) | 2/43 (5) (95% CI 4.78 to 5.22) | 4/43 (9) (95% CI 8.63 to 9.37) | 0.397 |
| Death within 15 days, no. (%) | 3/43 (7) (95% CI 6.70 to 7.30) | 10/43 (23) (95% CI 22.19 to 23.81) | 0.035 |
| Death within 30 days, no. (%) | 3/43 (7) (95% CI 6.70 to 7.30) | 13/43 (30) (95% CI 29.04 to 30.96) | 0.006 |
| 6 weeks mortality, no. (%)‡ | 3/43 (7) (95% CI 6.70 to 7.30) | 13/43 (30) (95% CI 29.04 to 30.96) | 0.006 |
| 6 weeks mortality, no. (%)§ | 3/39 (8) (95% CI 7.63 to 8.37) | 13/43 (30) (95% CI 29.04 to 30.96) | 0.0101 |
| 6 weeks mortality, no. (%)¶ | 3/10 (30) | 3/18 (16.7) | 0.4122 |
| Deaths according to Child-Pugh score | |||
| Child A, no. (%) | 0/14 (0) | 2/12 (17) (95% CI 14.70 to 19.30) | 0.112 |
| Child B, no. (%) | 0/21 (0) | 2/21 (10) (95% CI 9.16 to 10.84) | 0.147 |
| Child C, no. (%) | 3/8 (38) (95% CI 32.23 to 43.77) | 9/10 (90) (95% CI 88.24 to 91.76) | 0.019 |
*Before EBL±cyanoacrylate injection.
†Patients having no actively bleeding (spurter) during Early elective endoscopy.
‡BAVENO VI endpoint (BAVENO VI recommends mortality at 6 weeks to be a reasonable endpoint for RCTs.).
§Subgroup analysis after removing of the four patients that had been censored as treatment failures and failures of clinical haemostasis in the powder group.
¶Subgroup survival analysis comparing death in the subgroup of patients having positive blood culture within both groups.
EBL, endoscopic band ligation; RCT, randomised controlled trial.