Table 4.
Treatment-relateda adverse events data reported in included studies.
| Study | Treatment | Treatment-Related SAE | Treatment-Related Non-SAE |
|---|---|---|---|
| Nenezic 2019 [20,28] | VISTASEAL 2C | 2/168 (1.2%) | 2/168 (1.2%) |
| Possibly Related | Possibly Related | ||
| Cellulitis, B19V test positiveb | Vascular graft complication, B19V test positivec | ||
| Manual Compression | 0 | 0 | |
| Chetter 2017 [19] | VISTASEAL 1C | 1/187 (0.5%) | 1/187 (0.5%) |
| Possibly Related | Possibly Related | ||
| Post-Procedure Hemorrhage | Wound Infection | ||
| Manual Compression | 0 | 0 | |
| Saha 2012 [31] | TISSEEL 2C | 0 | 1/70 (1.4%) |
| Possibly Related | |||
| Intraoperative bleeding | |||
| Manual Compression | 0 | 1/70 (1.4%) | |
| Possibly Related | |||
| Postoperative hematoma | |||
| Saha 2011 [30] | TISSEEL 1C | 0 | 1/50 (2%) |
| TISSEEL 2C | 0 | Possibly Related | |
| Venous stenosis in the area of the anastomosis | |||
| Manual Compression | 0 | 1/23 (4.3%) | |
| Probably Related | |||
| Intraoperative rebleeding | |||
| Chalmers 2010 [29] | EVICEL 1C | NR | NR |
| Manual Compression | NR | NR |
Abbreviations: 1C = 1-min clotting time; 2C = 2-min clotting time; NR = not reported; SAE = serious adverse event.
a
Treatment-related defined as an adverse event definitely, probably, or possibly related to study treatment.
b
The data suggest that there was no treatment emergent viral infection.
c
The data suggest passive transmission of B19V IgG antibody with the transfusion of blood products.