International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain

Besselaar, A.M.H.P. van den; Chantarangkul, Veena; Angeloni, F; Binder, N B; Byrne, Mary; Dauer, Ray; Gudmundsdottir, Brynja R.; Jespersen, Jørgen; Kitchen, S.; Legnani, Cristina; Lindahl, Tomas; Manning, Richard A.; Martinuzzo, Marta; Panes, Olga; Pengo, Vittorio; Riddell, A; Subramanian, S.; Szederjesi, Attila; Tantanate, Chaicharoen; Herbel, P; Tripodi, Armando

doi:10.1111/jth.13879

Cited by 20 publications

(19 citation statements)

References 12 publications

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“…The International Standards were used with a manual tilt tube technique by two experienced operators who obtained very similar results for the MNPT (Table 1) as well as the mean INRs for the set of frozen plasma pools ( Table 2). The good agreement between our two operators contrasts with the wide variation between operators observed in multi-center studies [23]. It is not surprising that there is good agreement between the two operators because they used the same equipment and the same harmonized technique.…”

Section: Discussionmentioning

confidence: 41%

“…It is not known whether INRs of our frozen and freeze-dried plasmas, if determined with RBT/16 and rTF/16, would be the same as the values obtained with RBT/05 and rTF/09. Nevertheless, using a different set of freeze-dried plasmas, similar INRs were obtained with all four International Standards [23].…”

Section: Discussionmentioning

confidence: 58%

“…The relative differences between the direct INR procedure and the International Standard were acceptable for all commercial reagents if rTF/09 assigned values were used. In 2016 the International Standards RBT/05 and rTF/09 were replaced by their successors RBT/16 and rTF/16 [23]. It is not known whether INRs of our frozen and freeze-dried plasmas, if determined with RBT/16 and rTF/16, would be the same as the values obtained with RBT/05 and rTF/09.…”

Section: Discussionmentioning

confidence: 99%

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Assignment of international normalized ratio to frozen and freeze-dried pooled plasmas

Besselaar

Cobbaert

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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ObjectivesFrozen and freeze-dried plasmas may be used for local prothrombin time system calibration, for direct international normalized ratio (INR) determination, and for quality assessment. The purpose of the present study was to evaluate the usefulness of INRs assigned with various types of thromboplastins to frozen and freeze-dried pooled plasmas obtained from patients treated with vitamin K antagonists.MethodsINRs were calculated according to the international sensitivity index (ISI) model using various thromboplastins and instruments, i.e. International Standards for thromboplastin as well as six commercial reagents prepared from rabbit and bovine brain, and recombinant human tissue factor. The uncertainty of the INRs was assessed using the standard deviations of clotting times and ISI values. Commutability of the plasmas was assessed according to the approved Clinical and Laboratory Standards Institute (CLSI) Guideline EP30-A. Validation of a set of six frozen plasma pools for direct INR determination was performed according to the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (SSC/ISTH) guidelines.ResultsFor all frozen and freeze-dried plasmas, the INRs calculated with bovine thromboplastin Thrombotest were lower than the INRs assigned with other thromboplastins. With a few exceptions, the frozen and freeze-dried pooled plasmas were commutable. When the set of six frozen plasma pools was used for local calibration, the analytical bias of the INR was less than ±10% for all commercial reagents except Thrombotest.ConclusionsProcessing of fresh plasmas to prepare pooled frozen plasmas and freeze-dried plasmas may lead to different INR assignments depending on the thromboplastin used. Despite minor INR differences, a set of six frozen plasma pools could be used for local calibration by direct INR determination.

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Section: Discussionmentioning

confidence: 41%

Section: Discussionmentioning

confidence: 58%

Section: Discussionmentioning

confidence: 99%

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Assignment of international normalized ratio to frozen and freeze-dried pooled plasmas

Besselaar

Cobbaert

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…The INR is the most commonly used measure of coagulation in cirrhosis; however, the INR does not truly reflect coagulation in cirrhotic patients [7]. In fact, the INR was devised and validated for patients on a vitamin K antagonist [8]. Despite this, the INR is used often in clinical practice for cirrhotic patients, elucidating a difficulty in shifting away from this paradigm.…”

Section: Discussionmentioning

confidence: 99%

Coagulation in chronic liver disease and the use of prothrombin complex concentrate for an emergent procedure: a case report and review of literature

Laubham

Kallwitz

2018

Journal of Community Hospital Internal Medicine Perspectives

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Synthetic dysfunction observed in cirrhosis results in altered production of procoagulants and anticoagulants that can lead to both bleeding and thrombotic events, respectively. In patients with decompensated cirrhosis, frequent hospital visits often require bedside procedures such as diagnostic paracenteses, thoracenteses and endoscopy. It can be difficult to determine at what coagulation threshold procedures can safely be performed. Currently, the most common therapies given pre-procedurally include fresh frozen plasma (FFP) and vitamin K. The effectiveness of these treatments is estimated by international normalized ratio (INR), an imprecise measure of coagulation in the setting of cirrhosis. Transfusion with FFP may lead to detrimental side effects, including worsening volume overload and increased portal hypertension. We present a case of a 60-year-old patient intubated for acute hypoxic respiratory failure secondary to volume overload who subsequently developed bilateral pneumothoraces, requiring immediate chest tube placement. In this case, the patient had ongoing hepatic decompensation with volume overload and acute worsening of coagulopathy with an INR of 4.2. In this setting, 4-Factor Prothrombin Complex Concentrate (4F-PCC) was chosen to correct coagulation parameters with a low infusion volume. One hour following administration, INR was 1.5. Chest tubes were placed bilaterally and oxygenation improved without bleeding complications. While the data is still lacking, 4F-PCC may be considered for urgent and emergency situations in cirrhotic patients.

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“…3 Today, it is known that brain thromboplastin contains tissue factor (TF) and phospholipid-rich vesicles. 7 TF is the transmembrane receptor of coagulation factor VII(a) and is not detectable in blood or plasma under physiological conditions. 8 Upon vascular damage, blood becomes exposed to subendothelial TF, which triggers coagulation and thus contributes to hemostasis.…”

Section: Introductionmentioning

confidence: 99%

Human milk triggers coagulation via tissue factor–exposing extracellular vesicles

Hell²,

Kendlbacher³

et al. 2020

Blood Advances

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Almost a century ago, it was discovered that human milk activates the coagulation system, but the milk component that triggers coagulation had until now been unidentified. In the present study, we identify this component and demonstrate that extracellular vesicles (EVs) present in normal human milk expose coagulant tissue factor (TF). This coagulant activity withstands digestive conditions, mimicking those of breastfed infants, but is sensitive to pasteurization of pooled donor milk, which is routinely used in neonatal intensive care units. In contrast to human milk, bovine milk, the basis of most infant formulas, lacks coagulant activity. Currently, the physiological function of TF-exposing vesicles in human milk is unknown, but we speculate that these vesicles may be protective for infants. Another explanation could be nipple skin damage, which occurs in most breastfeeding women. Milk-derived TF-exposing EVs may seal the wound and thereby reduce bleeding and breast inflammation.

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International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain

Cited by 20 publications

References 12 publications

Assignment of international normalized ratio to frozen and freeze-dried pooled plasmas

Assignment of international normalized ratio to frozen and freeze-dried pooled plasmas

Coagulation in chronic liver disease and the use of prothrombin complex concentrate for an emergent procedure: a case report and review of literature

Human milk triggers coagulation via tissue factor–exposing extracellular vesicles

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