Administration of fibrinogen concentrate for refractory bleeding in massively transfused, non-trauma patients with coagulopathy: a retrospective study with comparator group

Abstract

Background: This retrospective, single centre study was conducted to investigate the efficacy of fibrinogen concentrate (FBNc) in decreasing blood requirements and reaching optimal fibrinogen level, in non-trauma, massively transfused, bleeding patients with coagulopathy.

Methods: Over a 3-years period, all patients for whom a massive transfusion protocol was activated and had received ≥ 4 units of allogeneic blood components within a ≤ 4 h period, were included. Patients were classified according to whether they received FBNc or achieved an optimal fibrinogen level of ≥ 2 g/L within 24 h after FBNc administration.

Results: Seventy-one patients received 2 [2,4] g of FBNc (FBNc group) and 72 did not (comparator group). FBNc was administered after transfusing 5 [5,9] blood component units, 3 [2,6] hours after massive transfusion protocol activation. Linear regression analysis showed that SOFA (AOR 0.75 [95% CI:0.08-1.43]) and admission fibrinogen level (AOR -2.7 [95% CI:-4.68 - -0.78]), but not FBNc administration, were independently associated with total transfused units. There was a significant inverse relation between both admission and target fibrinogen levels, and total transfused components. Logistic regression showed a direct relationship between admission fibrinogen level and achieving a target level ≥ 2 g/L (AOR 3.29 [95% CI;1.95-5.56]). No thromboembolic events associated with FBNc were observed.

Conclusions: In massively transfused, non-trauma patients with coagulopathy and refractory bleeding, late administration of low FBNc dosage was not associated with decreased blood transfusion or increased post-infusion fibrinogen level. Given that both fibrinogen upon admission and target fibrinogen levels were associated with decreased blood transfusion, earlier administration and higher doses of FBNc could be needed.

Keywords: Anaemia; Bleeding; Clauss method; FIBTEM; Fibrinogen concentrate; Goal directed therapy; Massive transfusion protocol; ROTEM; TEG; Thromboelastography; Thromboelastometry; Transfusion.

Figure 1

Current massive transfusion protocol (MTP) for management of patients with massive haemorrhage at University Hospital Virgen del Rocio, Seville (Spain).

Figure 2

Patients (N) included into a massive transfusion protocol. Comparisons were performed between: (1) patients receiving (FBNc group) or not (comparator group) fibrinogen concentrate (FBNc); (2) patients receiving (FBNc group) or not (comparator group) FBNc and successfully pair-matched by SOFA, age and diagnosis; and (3) patients achieving or not a fibrinogen level ≥2 g/l

Figure 3

Relationship between the global number of transfused units and fibrinogen levels upon admission (baseline) (a) and highest levels within 24-hours after activating massive transfusion protocol (b).