Table 3.
Protocol Violations
| Violations and Effects | 2006 Standard Protocol (n = 50) | 2006 Lower Target Protocol (n = 50) | 1996 Study1 (n = 50) | |||
|---|---|---|---|---|---|---|
| No protocol violations (no. and % of patients) | 34 | (68) | 37 | (74) | 18 | (36) |
| Protocol violations (no. and % of violations) | ||||||
| Total number of violations | 20 | 18 | 49 | |||
| Incorrect adjustment of infusion rate | 7 | (35) | 5 | (28) | 18 | (37) |
| Incorrect sampling time for initial PTT | 3 | (15) | 7 | (39) | 24 | (49)* |
| Incorrect bolus dose | 3 | (15) | 0 | 3 | (6) | |
| Incorrect infusion hold time | 3 | (15) | 1 | (6) | NA | |
| Omission of documentation of PTT | 2 | (10) | 0 | NA | ||
| Omission of PTT test(s) | 1 | (5) | 4 | (22) | 4 | (8) |
| Physician not notified | 1 | (5) | 1 | (6) | 0 | |
| Effect on primary outcomes (median and range) | ||||||
| Time to PTT > lower limit of therapeutic range (h) | ||||||
| For patients with no protocol violation | 6.0 | (4.0–26.5)† | 6.3 | (4.8–14.3)‡ | NA | |
| For patients with at least 1 protocol violation | 6.0 | (4.0–40.8)† | 11.1 | (5.5–53.0)‡ | NA | |
| Time to PTT within therapeutic range (h) | ||||||
| For patients with no protocol violation | 12.8 | (4.0–55.0)§ | 14.0 | (4.5–36.8)¶ | NA | |
| For patients with at least 1 protocol violation | 22.0 | (5.5–40.8)§ | 20.3 | (6.0–53.0)¶ | NA | |
NA = not applicable, PTT = partial thromboplastin time.
*
For 1996 study, this value refers to incorrect sampling time for any PTT.
†
p = 0.59, for comparison between group with no protocol violations and group with at least 1 protocol violation.
‡
p = 0.04, for comparison between group with no protocol violations and group with at least 1 protocol violation
§
p = 0.017, for comparison between group with no protocol violations and group with at least 1 protocol violation
¶
p = 0.08, for comparison between group with no protocol violations and group with at least 1 protocol violation.