Summary of outcomes and factor levels in studies that reported information at the procedure level
| Outcomes . | Study . | FVIII levels (IU/mL) . | VWF levels (IU/mL) . | ||
|---|---|---|---|---|---|
| Mean (range) . | Median (IQR) . | Mean (range) . | Median (IQR) . | ||
| Hemostatic efficacy | |||||
| Excellent, 74%; good, 11%; fair, 5%; poor, 11%* | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Excellent, 84%; good, 16%† | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| 100%‡ | Dunkley et al17 | 1.15 (0.97-1.34) | 0.85 (0.67-1.03) | ||
| Major bleeding | |||||
| 5%* | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| 0§ | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| Hgb decreased to ≥1.24 mmol/L and/or RBC transfusion | |||||
| 6.70%§ | Srivastava et al20 | 0.92 (0.82-1.02) | 0.41 (0.32-0.50) | ||
| 3% RBC transfusionǁ | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| 20% RBC transfusionǁ | Dunkley et al17 | 1.15 (0.97-1.34) | 0.85 (0.67-1.03) | ||
| Symptomatic VTE | |||||
| 0.00% | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| 0% | Srivastava et al20 | 0.92 (0.82-1.02) | 0.41 (0.32-0.50) | ||
| Wound infection | |||||
| 0.00% | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Received ≥2 units RBCs | |||||
| 58.00%¶ | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Estimated blood loss | |||||
| Mean, 427 mL (SD, 70-1500 mL) | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Duration of hospitalization | |||||
| Mean, 5 days (range, 3-13 days) | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Outcomes . | Study . | FVIII levels (IU/mL) . | VWF levels (IU/mL) . | ||
|---|---|---|---|---|---|
| Mean (range) . | Median (IQR) . | Mean (range) . | Median (IQR) . | ||
| Hemostatic efficacy | |||||
| Excellent, 74%; good, 11%; fair, 5%; poor, 11%* | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Excellent, 84%; good, 16%† | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| 100%‡ | Dunkley et al17 | 1.15 (0.97-1.34) | 0.85 (0.67-1.03) | ||
| Major bleeding | |||||
| 5%* | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| 0§ | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| Hgb decreased to ≥1.24 mmol/L and/or RBC transfusion | |||||
| 6.70%§ | Srivastava et al20 | 0.92 (0.82-1.02) | 0.41 (0.32-0.50) | ||
| 3% RBC transfusionǁ | Borel-Derlon et al16 | 2.40 (1.00-3.14) | 0.94 (0.48-1.36) | ||
| 20% RBC transfusionǁ | Dunkley et al17 | 1.15 (0.97-1.34) | 0.85 (0.67-1.03) | ||
| Symptomatic VTE | |||||
| 0.00% | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| 0% | Srivastava et al20 | 0.92 (0.82-1.02) | 0.41 (0.32-0.50) | ||
| Wound infection | |||||
| 0.00% | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Received ≥2 units RBCs | |||||
| 58.00%¶ | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Estimated blood loss | |||||
| Mean, 427 mL (SD, 70-1500 mL) | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
| Duration of hospitalization | |||||
| Mean, 5 days (range, 3-13 days) | Rugeri et al19 | 1.74 (1.53-2.20) | 2.10 (0.87-2.10) | ||
Hgb, hemoglobin; IQR, interquartile range; RBC, red blood cell; SD, standard deviation; VTE, venous thromboembolism.
Outcomes definitions based on International Society on Thrombosis and Haemostasis definitions.
Excellent: bleeding during surgery and the postoperative period similar to that expected for normal individuals; good: slightly excessive bleeding.
Excellent: hemostasis achieved and cessation of bleeding; good: partial but adequate control of bleeding and did not require additional product for unplanned treatment; moderate: moderate control of bleeding and required additional product for unplanned treatment; none: severe uncontrolled bleeding.
The author did not provide information on the outcome definition.
Includes intraoperative (allogeneic and cell saver) transfusion and postoperative allogeneic transfusion.