Table 3.
Published studies of treatment regimens for coagulopathy following pediatric trauma.
| Intervention | Study design | Number of subjects | References | Year | Study population | Main Results |
|---|---|---|---|---|---|---|
| PCC | Case Report | 1 | [88] | 2011 | 8 kg infant with liver trauma and severe hemorrhage | Patient with acidosis (pH 6.67) and severe anemia (Hb 4 mg/dL). Poorly controlled bleeding despite surgical intervention, FFP and platelets. Vit K and 30 IU/kg PCC administered, with rapid cessation of bleeding and INR ↓ from 2.9 to 1.5. |
| rFVIIa | Case Reports | 3 | [84] | 2003 | 5 wks, 20 mo and 1 yr old with (T)BI | One patient received rFVIIa (bolus of 90 μg/kg) after failing of repeated FFP to correct coagulopathy; two patients received rFVIIa as initial therapy. Two of three children had good neurologic outcomes; third progressed to brain death. No thrombotic complications; intracranial devices placed w/o intracranial hemorrhage. |
| rFVIIa | Retrospective case series | 135 | [83] | 2009 | Pediatric patients receiving rFVIIa | Median transfusion volume decreased in the 24 hours after rFVIIa vs. prior 24 hrs. (11.7 mL/kg vs. 29.7 mL/kg). Mortality lower in surgical/trauma patients (16%) compared to medical patients (58%). Three thrombotic events resulted in two deaths. |
| Fibrinogen | Case Report | 1 | [80] | 2013 | 20 kg, 7 year old with severe abdominal and pelvic trauma | EBL of >70 mL/kg. Goal-directed therapy with ROTEM resulted in administration of 2 g fibrinogen and 3 u of RBC with no FFP or platelets. The ratio of intra-operative fibrinogen concentrate (g) to RBC (U) was 0.7 |
| MT | Prospective | 53 | [110] | 2012 | Pediatric trauma patients | Outcome data compared before and after institution of pediatric MTP. Median FFP: RBC ratio was higher after MTP (1:1.8 vs. 1:3.6). Time to FFP dosing decreased 4-fold with MTP. No difference in mortality. |
| MT | Prospective cohort | 55 | [113] | 2012 | Pediatric patients requiring un–cross-matched blood | Coagulopathy, aPTT >36 s associated with initiation of MTP. ISS for the MTP group was 42 vs 25 for the non–MTP group. More thromboembolic complications in the non–MTP group. No difference in mortality. |
| Therapeutic | ||||||
| Level IV | ||||||
| MT | Retrospective cohort | 105 | [114] | 2013 | Pediatric trauma patients < 18 yo requiring massive transfusion | Higher plasma/RBC and platelet/RBC ratios were not associated with increased survival. |
PCC= Prothrombin Complex Concentrate. FFP=fresh frozen plasma INR= International Normalized Ratio. TBI= traumatic brain injury. rFVIIa= recombinant Factor VII. U=unit. EBL= estimated blood loss. MT= Massive Transfusion. MTP=massive transfusion protocol. RBC=red blood cell.. aPTT = Activated partial thromboplastin time. ISS= Injury Severity Score.