Outcomes of the studies included in the systematic review
| Reference . | Effective management of major bleeding . | ISTH criteria used (Y/N) . | Patients with effective vs ineffective management of major bleeding, no. (%) . | Mortality definition . | Mortality rate, no. (%) . | Thromboembolic complications definition . | Thromboembolic rate, no. (%) . |
|---|---|---|---|---|---|---|---|
| 34 | Absence of progression of ICH on CT of the head, stabilization of bleeding on endoscopy, or cessation of surgical bleeding | N | Effective, 5 (83.3); ineffective, 1 (16.7) had progression of ICH with fatal ICH | 90-day mortality | 2 (33.3); 1 sepsis, 1 fatal ICH | PE, DVT, MI, or CVA | 0 (0) |
| 35 | Absence of progression of ICH on CT of the head or bleeding complication after neurosurgical intervention | N | Effective, 17 (94.5); ineffective, 1 (5.5) had progression of ICH | In-hospital mortality and 90-day Modified Rankin Scale (0 = no symptoms to 6 = dead) | 6 (33); 2 pneumonia, 4 withdrawal of care | PE, DVT, or MI | 1 (5.5) PE |
| 36 | Absence of progression of ICH on CT of the head or stabilization of bleeding on endoscopy | N | Effective, 3 (100); ineffective, 0(0) | In-hospital mortality and mortality within 180 days after discharge | 0 (0) | Not reported | NA |
| 37 | Intraoperative surgical assessment of bleeding during neurosurgical intervention (strong bleeding vs normal) | N | Effective, 1 (33.3) normal intraoperative bleeding; ineffective, 2 (66.7) strong intraoperative bleeding; intraoperative bleeding was unspecified in 3 patients | Glasgow Outcome Scale (5 = low disability to 1 = death) | 2 (33.3) | Not reported | NA |
| 39 | Bleeding rated as effective or ineffective based on ISTH criteria for 4 different types of bleeding: visible, musculoskeletal, intracranial, or nonvisible | Y | Effective, 58 (69); ineffective, 26 (31) | 30-day mortality | 27 (32); 18 ICH, 7 sepsis and multiorgan failure, 1 cardiac rrhythmia, 1 cardiac arrest | Objectively verified arterial (stroke, MI or arterial thromboembolism) or VTE (DVT or PE) | 2 (2) ischemic stroke; 1 patient 5 days after and the other 10 days after PCC |
| 40 | Absence of progression of ICH on CT of the head or the need for surgical evacuation | N | Effective, 3 (33); ineffective, 6 (67) | In-hospital mortality and mortality within 7 days after PCC administration; Modified Rankin Scale (0 = no symptoms to 6 = dead) at discharge | 0 (0) | Not defined | 0 (0) |
| 41 | The primary outcome measure was occurrence of hematoma enlargement defined as a relative parenchymal volume increase of >33% from the initial follow-up imaging | N | Effective, 61 (65); Ineffective, 33 (35) | In-hospital mortality, 3-month mortality and 3-month Modified Rankin Scale score were reported for all patients and not for patients receiving direct FXa inhibitors | Mortality rate among all patients: 29 (19.9) of 146 at discharge; 43 (29.5) of 146 at 3 months; mortality rate not reported separately for the 94 patients receiving direct FXa inhibitor who received PCC | Not reported | NA |
| 42 | Hematoma expansion rate | N | Effective, 13 (93%); Ineffective, 1 (7%) | In-hospital mortality | 2 (14) | MI, DVT, PE, and ischemic stroke within 30 days | 0 (0) |
| 38 | Bleeding rated as good, moderate, or poor using an effectiveness assessment guide. In post hoc analysis, bleeding was also rated as effective or ineffective based on ISTH criteria for 4 different types of bleeding: visible, musculoskeletal, intracranial, or other nonvisible | Y | Good for 43 (65) patients (95% CI, 53-77), moderate for 13 (20) (95% CI, 10-30), and poor/none for 10 (15) (95% CI, 6-24). Post hoc analysis using the ISTH criteria: effective: 45 (68); ineffective: 21 (32) | 30-day mortality | 9 (14): 8 had ICH, 7 of these deaths were adjudicated as a result of the index ICH event, 1 died as a result of self-inflicted stab wounds to the chest | Primary safety outcome: symptomatic DVT, PE, ischemic stroke, heart valve or cardiac chamber thrombosis, symptomatic peripheral arterial thrombosis or myocardial infarction within 7 days after PCC administration; secondary safety outcome: 30-day thromboembolic event rate | 5 (8) major thromboembolic event 7-day rate, 2 (3); 8- to 30-day rate, 3 (5) |
| 43 | The hemostatic efficacy was determined by the treating physician on the basis of clinical measures, including patient hemodynamics, trend of hemoglobin and hematocrit, and active bleeding as seen on imaging or with invasive procedures | N | Effective, 40 (93); ineffective, 3 (7) continued to have active bleeding. Two patients (4.6) died as a result of hemorrhage and 1 required surgery to achieve hemostasis | Not reported | Two patients (4.6) died as a result of hemorrhage | Acute DVT, PE, MI, or acute coronary syndrome, transient ischemic stroke, cerebral vascular accidents, and arterial thrombosis of limb or mesentery | 2 (4.6); 1 (2.3) had a DVT within 14 days after PCC administration, 1 (2.3) had a subsegmental PE 3 months after receiving PCC |
| Reference . | Effective management of major bleeding . | ISTH criteria used (Y/N) . | Patients with effective vs ineffective management of major bleeding, no. (%) . | Mortality definition . | Mortality rate, no. (%) . | Thromboembolic complications definition . | Thromboembolic rate, no. (%) . |
|---|---|---|---|---|---|---|---|
| 34 | Absence of progression of ICH on CT of the head, stabilization of bleeding on endoscopy, or cessation of surgical bleeding | N | Effective, 5 (83.3); ineffective, 1 (16.7) had progression of ICH with fatal ICH | 90-day mortality | 2 (33.3); 1 sepsis, 1 fatal ICH | PE, DVT, MI, or CVA | 0 (0) |
| 35 | Absence of progression of ICH on CT of the head or bleeding complication after neurosurgical intervention | N | Effective, 17 (94.5); ineffective, 1 (5.5) had progression of ICH | In-hospital mortality and 90-day Modified Rankin Scale (0 = no symptoms to 6 = dead) | 6 (33); 2 pneumonia, 4 withdrawal of care | PE, DVT, or MI | 1 (5.5) PE |
| 36 | Absence of progression of ICH on CT of the head or stabilization of bleeding on endoscopy | N | Effective, 3 (100); ineffective, 0(0) | In-hospital mortality and mortality within 180 days after discharge | 0 (0) | Not reported | NA |
| 37 | Intraoperative surgical assessment of bleeding during neurosurgical intervention (strong bleeding vs normal) | N | Effective, 1 (33.3) normal intraoperative bleeding; ineffective, 2 (66.7) strong intraoperative bleeding; intraoperative bleeding was unspecified in 3 patients | Glasgow Outcome Scale (5 = low disability to 1 = death) | 2 (33.3) | Not reported | NA |
| 39 | Bleeding rated as effective or ineffective based on ISTH criteria for 4 different types of bleeding: visible, musculoskeletal, intracranial, or nonvisible | Y | Effective, 58 (69); ineffective, 26 (31) | 30-day mortality | 27 (32); 18 ICH, 7 sepsis and multiorgan failure, 1 cardiac rrhythmia, 1 cardiac arrest | Objectively verified arterial (stroke, MI or arterial thromboembolism) or VTE (DVT or PE) | 2 (2) ischemic stroke; 1 patient 5 days after and the other 10 days after PCC |
| 40 | Absence of progression of ICH on CT of the head or the need for surgical evacuation | N | Effective, 3 (33); ineffective, 6 (67) | In-hospital mortality and mortality within 7 days after PCC administration; Modified Rankin Scale (0 = no symptoms to 6 = dead) at discharge | 0 (0) | Not defined | 0 (0) |
| 41 | The primary outcome measure was occurrence of hematoma enlargement defined as a relative parenchymal volume increase of >33% from the initial follow-up imaging | N | Effective, 61 (65); Ineffective, 33 (35) | In-hospital mortality, 3-month mortality and 3-month Modified Rankin Scale score were reported for all patients and not for patients receiving direct FXa inhibitors | Mortality rate among all patients: 29 (19.9) of 146 at discharge; 43 (29.5) of 146 at 3 months; mortality rate not reported separately for the 94 patients receiving direct FXa inhibitor who received PCC | Not reported | NA |
| 42 | Hematoma expansion rate | N | Effective, 13 (93%); Ineffective, 1 (7%) | In-hospital mortality | 2 (14) | MI, DVT, PE, and ischemic stroke within 30 days | 0 (0) |
| 38 | Bleeding rated as good, moderate, or poor using an effectiveness assessment guide. In post hoc analysis, bleeding was also rated as effective or ineffective based on ISTH criteria for 4 different types of bleeding: visible, musculoskeletal, intracranial, or other nonvisible | Y | Good for 43 (65) patients (95% CI, 53-77), moderate for 13 (20) (95% CI, 10-30), and poor/none for 10 (15) (95% CI, 6-24). Post hoc analysis using the ISTH criteria: effective: 45 (68); ineffective: 21 (32) | 30-day mortality | 9 (14): 8 had ICH, 7 of these deaths were adjudicated as a result of the index ICH event, 1 died as a result of self-inflicted stab wounds to the chest | Primary safety outcome: symptomatic DVT, PE, ischemic stroke, heart valve or cardiac chamber thrombosis, symptomatic peripheral arterial thrombosis or myocardial infarction within 7 days after PCC administration; secondary safety outcome: 30-day thromboembolic event rate | 5 (8) major thromboembolic event 7-day rate, 2 (3); 8- to 30-day rate, 3 (5) |
| 43 | The hemostatic efficacy was determined by the treating physician on the basis of clinical measures, including patient hemodynamics, trend of hemoglobin and hematocrit, and active bleeding as seen on imaging or with invasive procedures | N | Effective, 40 (93); ineffective, 3 (7) continued to have active bleeding. Two patients (4.6) died as a result of hemorrhage and 1 required surgery to achieve hemostasis | Not reported | Two patients (4.6) died as a result of hemorrhage | Acute DVT, PE, MI, or acute coronary syndrome, transient ischemic stroke, cerebral vascular accidents, and arterial thrombosis of limb or mesentery | 2 (4.6); 1 (2.3) had a DVT within 14 days after PCC administration, 1 (2.3) had a subsegmental PE 3 months after receiving PCC |
MI, myocardial infarction; N, no; Y, yes.