Table 2.
Characteristics of randomized controlled trials on the role of calcium channel blockers in TBI [4]
Study | Compton11 | HIT I50 | HIT II1 | HIT III21 | HIT IV45 | Sahuquillo39 |
---|---|---|---|---|---|---|
Setting | Britain | Europe | Europe | Germany | International (13 countries) | Spain |
Sample | ||||||
Total (n) | 31 | 351 | 852 | 123 | 592 | 22 |
Treatment (n) | 20 | 176 | 423 | 63 | 290 | 11 |
Placebo (n) | 11 | 175 | 429 | 60 | 287 | 11 |
Inclusion | severe TBI vasospasm on TCD | moderate, severe TBI | Moderate TBI | tSAH | tSAH | moderate, severe TBI |
tSAH subgroup included | no | yes | yes | yes | yes | no |
Intervention | nicardipine | nimodipine | nimodipine | nimodipine | nimodipine | nicardipine |
Reported risks: | ||||||
• Unfavorable Outcome (mortality, severe disability, persistent vegetative state) | no | yes (yes – tSAH group) | yes (yes – tSAH group) | yes (yes – tSAH group) | yes | yes |
• Death | yes | yes | yes (yes – tSAH group) | yes (yes – tSAH group) | no | yes |
• Side effects (hypotension, increase in pancreatic/liver enzymes) | no | yes | yes | yes | no | no |