Table 3. Objective criteria used for determination of the secondary endpoint of global haemostatic response, adapted from Sarode et al31.
| Global haemostatic response | Haemostatic intervention | Drop in haemoglobin | |
| Excellent (positive) | No additional haemostatic interventions* administered between 60 min and 24 hours after initiation of infusion† | AND | <15% decrease in haemoglobin between 60 min and 24 hours after initiation of infusion†‡ |
| Good (positive) | No additional haemostatic interventions* administered between 60 min and 24 hours after initiation of infusion† | AND | 15% to <30% decrease in haemoglobin between 60 min and 24 hours after initiation of infusion†‡ |
| Poor (negative) | Additional haemostatic interventions* administered between 60 min and 24 hours after initiation of infusion† | OR | ≥30% decrease in haemoglobin between 60 min and 24 hours after initiation of infusion†‡ |
*
Administration of any systemic haemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII, other coagulation factor products or a second dose of IMP) or any haemostatic interventions (including surgical re-opening for bleeding).
†
The 60-minute min period allows for the administration of the IMP and establishment of treatment effect.
‡
Each unit of RBC transfused during this time period will be counted as a drop of 1.0 g/dL g/dL in haemoglobin.
IMPinvestigational medicinal productRBCred blood cell