Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery

Rahe‐Meyer, Niels; Solomon, Cristina; Winterhalter, Michael; Piepenbrock, S.; Tanaka, Kenichi A.; Haverich, Axel; Pichlmaier, Maximilian

doi:10.1016/j.jtcvs.2008.11.065

Cited by 197 publications

(197 citation statements)

References 36 publications

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“…We also found a robust correlation between FibTEM MCF and A5 [7], which was confirmed in subsequent studies [20,21]. There is also a strong reported correlation between FibTEM A5 measurements and fibrinogen levels [22][23][24][25][26][27][28].…”

Section: Discussionsupporting

confidence: 84%

Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage

et al. 2014

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SummaryWe compared blood component requirements during major obstetric haemorrhage, following the introduction of fibrinogen concentrate. A prospective study of transfusion requirements and patient outcomes was performed for 12 months to evaluate the major obstetric haemorrhage pathway using shock packs (Shock Pack phase). The study was repeated after the pathway was amended to include fibrinogen concentrate (Fibrinogen phase).

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Section: Discussionsupporting

confidence: 84%

Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage

et al. 2014

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“…Although an improved Δ MCF was noted in the study by Lance and colleagues [11], this difference did not translate to a reduction in ABT utilization. Overall, thrombotic events were similar in both the intervention group and the comparator arm, with an overall low incidence rate [10][11][12][13][14][15].…”

Section: Efficacy and Safety Outcomes In Cardiac Surgerymentioning

confidence: 86%

“…Compared to studies that used PCC to reverse warfarin anticoagulation, FIBC studies more commonly involved conflicts of interest and industry funding. With these latter studies, the sample size in the prospective arms was generally small (mean, 12; range, [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]; and the historical comparator cohorts were not well matched to the intervention arm groups. Therefore, with the exception of randomized controlled trials by Karlsson and colleagues (2009) [10] and Fenger-Eriksen and colleagues (2009) [18], most studies were assessed to have a high degree of methodological bias.…”

Section: Discussionmentioning

confidence: 99%

“…Five prospective studies in this clinical grouping demonstrated reductions in ABT requirements [10,[12][13][14][15], of which 4 showed reduction in 24-hour chest tube drainage [10,[13][14][15] compared to the comparator arm (Table 5A). The study by Karlsson and colleagues [10] was assessed to have the lowest overall risk of methodological bias overall; the study reports that a prophylactic 2-g dose of FIBC given preoperatively in patients undergoing elective CABG surgery reduces chest tube drainage postoperatively (P b .01).…”

Section: Efficacy and Safety Outcomes In Cardiac Surgerymentioning

confidence: 99%

“…Overall, we identified 6 prospective [10][11][12][13][14][15] and 2 retrospective [16,17] studies in the cardiac surgery grouping. Of the 6 prospective studies, 3 were randomized and 3 were nonrandomized.…”

Section: Cardiac Surgerymentioning

confidence: 99%

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Use of Prothrombin Complex Concentrates and Fibrinogen Concentrates in the Perioperative Setting: A Systematic Review

Lin

Murphy

Tran

2013

Transfusion Medicine Reviews

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The use of prothrombin complex concentrates (PCCs) and fibrinogen concentrates (FIBCs) to achieve hemostasis in the perioperative setting as alternatives to allogeneic blood products remains controversial. To examine the efficacy and safety of PCCs and FIBCs, we conducted a systematic review-in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement-to compare the use of these transfusion alternatives in bleeding surgical patients. We performed a literature search of English articles published between July 1997 and July 2012 in MEDLINE via PubMed, The Cochrane Library, and CINAHL. Five randomized trials and 15 nonrandomized studies with a comparator group were included in the final review. Studies were sorted into 1 of the following 3 clinical settings: cardiac surgery, non-cardiac surgery, and reversal of warfarin anticoagulation. Risk of bias was assessed using the Cochrane risk of bias tool. With the exception of 2 randomized controlled trials, the existing body of literature on the use of PCCs and FIBCs in the perioperative setting was assessed to have a high degree of methodological bias. Overall, prospective studies in the cardiac surgery grouping suggested that patients receiving FIBC and/or PCCs required less allogeneic blood transfusion and had less chest tube drainage. In studies of warfarin reversal, PCCs more rapidly corrected the International Normalized Ratio compared to plasma; however, in the setting of intracranial hemorrhage, functional outcomes were poor regardless of the reversal strategy. With regards to safety outcomes, reporting was not uniform and raises concerns of underreporting. Adequately powered, methodologically sound trials would be required for more definitive conclusions to be drawn about the efficacy of PCCs and FIBC over conventional blood components for the treatment of perioperative coagulopathy in bleeding patients.

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Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery

Bilecen

Groot

Kalkman

et al. 2017

JAMA

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IMPORTANCE Fibrinogen concentrate might partly restore coagulation defects and reduce intraoperative bleeding.OBJECTIVE To determine whether fibrinogen concentrate infusion dosed to achieve a plasma fibrinogen level of 2.5 g/L in high-risk cardiac surgery patients with intraoperative bleeding reduces intraoperative blood loss. DESIGN, SETTING, AND PARTICIPANTSA randomized, placebo-controlled, double-blind clinical trial conducted in Isala Zwolle, the Netherlands (February 2011-January 2015), involving patients undergoing elective, high-risk cardiac surgery (ie, combined coronary artery bypass graft [CABG] surgery and valve repair or replacement surgery, the replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch) with intraoperative bleeding (blood volume between 60 and 250 mL suctioned from the thoracic cavity in a period of 5 minutes) were randomized to receive either fibrinogen concentrate or placebo.INTERVENTIONS Intravenous, single-dose administration of fibrinogen concentrate (n = 60) or placebo (n = 60), targeted to achieve a postinfusion plasma fibrinogen level of 2.5 g/L.MAIN OUTCOMES AND MEASURES The primary outcome was blood loss in milliliters between intervention (ie, after removal of cardiopulmonary bypass) and closure of chest. Safety variables (within 30 days) included: in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal insufficiency or failure, venous thromboembolism, pulmonary embolism, and operative complications. RESULTS Among 120 patients (mean age; 71 [SD, 10] years, 37 women [31%]) included in the study, combined CABG and valve repair or replacement surgery comprised 72% of procedures and had a mean (SD) cardiopulmonary bypass time of 200 minutes (83) minutes. For the primary outcome, median blood loss in the fibrinogen group was 50 mL (interquartile range [IQR], 29-100 mL) compared with 70 mL (IQR, 33-145 mL) in the control group (P = .19), the absolute difference 20 mL (95% CI, −13 to 35 mL). There were 6 cases of stroke or transient ischemic attack (4 in the fibrinogen group); 4 myocardial infarctions (3 in the fibrinogen group); 2 deaths (both in the fibrinogen group); 5 cases with renal insufficiency or failure (3 in the fibrinogen group); and 9 cases with reoperative thoracotomy (4 in the fibrinogen group).CONCLUSIONS AND RELEVANCE Among patients with intraoperative bleeding during high-risk cardiac surgery, administration of fibrinogen concentrate, compared with placebo, resulted in no significant difference in the amount of intraoperative blood loss.

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Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery

Abstract: FIBTEM-guided post-cardiopulmonary bypass administration of fibrinogen concentrate resulted in improved intraoperative management of coagulopathic bleeding in thoracoabdominal aortic aneurysm operations and reduced transfusion and 24-hour drainage volume.

Cited by 197 publications

References 36 publications

Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage

Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage

Use of Prothrombin Complex Concentrates and Fibrinogen Concentrates in the Perioperative Setting: A Systematic Review

Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery

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