The Effect of Factor XIII on Bleeding in Coronary Surgery

Gödje, O.; Haushofer, M; Lamm, Peter; Reichart, B.

doi:10.1055/s-2007-1010236

Cited by 58 publications

(56 citation statements)

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“…Acquired factor XIII deficiency is common following cardiopulmonary bypass (147)(148)(149)(150) and children may be particularly susceptible to the deficiency. In children undergoing open heart surgery for congenital cardiac defects, those with low factor XIII levels have a higher risk for developing myocardial edema requiring delayed sternal closure (151).…”

Section: Role Of Transglutaminases In Vascular Permeabilitymentioning

confidence: 99%

Roles of transglutaminases in cardiac and vascular diseases

Sane

Kontos²,

Greenberg³

2007

Front Biosci

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All transglutaminases share the common enzymatic activity of transamidation, or the cross-linking of glutamine and lysine residues to form N epsilon (gamma-glutamyl) lysyl isopeptide bonds. The plasma proenzyme factor XIII is responsible for stabilizing the fibrin clot against physical and fibrinolytic disruption. Another member of the transglutaminase family, tissue transglutaminase or TG2 is abundantly expressed in cardiomyocytes, vascular cells and macrophages. The transglutaminases have a variety of functions independent of their transamidating activity. For example, TG2 binds and hydrolyzes GTP, thereby fostering signal transduction by several G protein coupled receptors. Accumulating evidence points to novel roles for factor XIII and TG2 in cardiovascular biology including: (a) modulating platelet activity, (b) regulating glucose control, (c) contributing to the development of hypertension, (d) influencing the progression of atherosclerosis, (e) regulating vascular permeability and angiogenesis (f) and contributing to myocardial signaling, contractile activity and ischemia/reperfusion injury. In this review, we summarize the cardiovascular biology of two members of the family of transglutaminases, Factor XIII and TG2.

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Section: Role Of Transglutaminases In Vascular Permeabilitymentioning

confidence: 99%

Roles of transglutaminases in cardiac and vascular diseases

Sane

Kontos²,

Greenberg³

2007

Front Biosci

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“…Moreover, the FDA approval of Fibrogammin/Corifact for routine prophylaxis and perioperative bleeding management in congenital FXIII deficiency was based on the confirmed efficacy and safety profile established in 12 clinical trials with a total of 187 patients receiving 3,930 doses [12]. Fibrogammin/Corifact has also been shown to be efficacious in cases of acquired FXIII deficiency, such as reducing bleeding in ulcerative colitis [13], minimizing the incidence of myocardial edema during cardiac surgery in newborns and young children with congenital heart disease [14], reducing bleeding and transfusion requirements, and improving clot firmness during surgery [15,16,17], and reducing bleeding and red blood cell (RBC) transfusion requirements following stem cell transplantation [18,19]. …”

Section: Introductionmentioning

confidence: 99%

Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

Solomon

Korte

Fries

et al. 2016

Transfus Med Hemother

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Background: Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods: Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results: Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion: Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile.

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“…[1] (Havel et al, 1991); [2] (Shainoff et al, 1994); [3] (Chandler et al, 2001); [4] (Chandler and Velan 2003); [5] (Godje et al, 1998); [6] (Boisclair et al, 1993); [7] (Teufelsbauer et al, 1992); [8] (Hunt et al, 1998). were observed (Table 4) and attributed to blood loss, hemodilution and activation, the latter of which was demonstrated by elevated PF4 and β-TG concentrations during the ECC period (Table 3). Evidence of coagulation system activation was demonstrated by a doubling of TAT complex during the ECC period, despite hemodilution and adequate heparinization of study animals as demonstrated by suitably prolonged ACT values of >400 s. D-dimer concentrations appeared to be relatively insensitive to ECC, despite evidence of coagulation activation, and no remarkable changes were observed during the post-ECC period (Table 3).…”

Section: Clinical and Anatomic Pathology Of Ecc Study Animalsmentioning

confidence: 99%

Safety of Recombinant Human Factor XIII in a Cynomolgus Monkey Model of Extracorporeal Blood Circulation

Ponce¹,

Armstrong

Andrews

et al. 2005

Toxicol Pathol

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Factor XIII (FXIII) is a thrombin-activated plasma coagulation factor critical for blood clot stabilization and longevity. Administration of exogenous FXIII to replenish depleted stores after major surgery, including cardiopulmonary bypass, may reduce bleeding complications and transfusion requirements. Thus, a model of extracorporeal circulation (ECC) was developed in adult male cynomolgus monkeys (Macaca fascicularis) to evaluate the nonclinical safety of recombinant human FXIII (rFXIII). The hematological and coagulation profile in study animals during and after 2 h of ECC was similar to that reported for humans during and after cardiopulmonary bypass, including observations of anemia, thrombocytopenia, and activation of coagulation and platelets. Intravenous slow bolus injection of 300 U/kg (2.1 mg/kg) or 1000 U/kg (7 mg/kg) rFXIII after 2 h of ECC was well tolerated in study animals, and was associated with a dose-dependent increase in FXIII activity. No clinically significant effects in respiration, ECG, heart rate, blood pressure, body temperature, clinical chemistry, hematology (including platelet counts), or indicators of thrombosis (thrombin:antithrombin complex and D-Dimer) or platelet activation (platelet factor 4 and beta-thromboglobulin) were related to rFXIII administration. Specific examination of brain, heart, lung, liver, and kidney from rFXIII-treated animals provided no evidence of histopathological alterations suggestive of subclinical hemorrhage or thrombosis. Taken as a whole, the results demonstrate the ECC model suitably replicated the clinical presentation reported for humans during and after cardiopulmonary bypass surgery, and do not suggest significant concerns regarding use of rFXIII in replacement therapy after extracorporeal circulation.

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The Effect of Factor XIII on Bleeding in Coronary Surgery

Abstract: Factor XIII influences bleeding after coronary surgery and can reduce the need for blood transfusions. In patients with prolonged diffuse bleeding, we therefore recommend substitution of Factor XIII.

Cited by 58 publications

References 0 publications

Roles of transglutaminases in cardiac and vascular diseases

Roles of transglutaminases in cardiac and vascular diseases

Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

Safety of Recombinant Human Factor XIII in a Cynomolgus Monkey Model of Extracorporeal Blood Circulation

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