Clots were formed from 30% PNP or FDP supplemented with cryoprecipitate, RiaSTAP® (CSL Behring GmbH, Marburg, Germany) or FibCLOT® (LFB, Les Ulis, France) (0.5–2 mg/mL) in the presence of 16 mM phospholipids (Rossix, Mölndal, Sweden) ± 300 pM tPA (Alteplase (Actilyse®) Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany) in Tris buffered saline with Tween-20 (TBST; 10 mM Tris, 140 mM NaCl and 0.01% Tween-20 pH 7.4). Clotting was initiated with CaCl2 (10.6 mM) and thrombin (0.1 U/mL, Sigma Aldrich Sigma-Aldrich, Darmstadt, Germany), and absorbance readings were taken every min for 4 h at 37 °C in a in a FLX-800 plate reader (Biotek Instruments, Winooski, VT, USA).
Riastap
Manufactured by CSL Behring
Sourced in Germany
RiaSTAP is a medical device used for the measurement of fibrinogen, a blood clotting protein, in a laboratory setting. It utilizes the Radioimmunoassay (RIA) technique to quantify the concentration of fibrinogen in patient samples.
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8 protocols using riastap
1
Clot Formation Assay with Fibrinogen Supplements
2
Fibrinogen Concentrate for Trauma Hemorrhage
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This is a single-centre randomized, double-blinded, controlled, investigator-initiated, pilot phase II trial of 40 haemorrhaging trauma patients admitted to the Level 1 Trauma Centre in Copenhagen, Denmark randomized to administration of fibrinogen concentrate (Riastap®, CSL Behring Scandinavia, Danderyd, Sweden), as compared to placebo (saline), as immediate, pre-emptive first-line treatment of trauma haemorrhage, when haemostatic resuscitation is needed.
3
Fibrinogen Augmentation in Aortic Surgery
4
Retrospective Study of Trauma Patients
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This descriptive, retrospective register study of adult trauma patients treated at the TCK, the Stockholm region’s level 1 trauma unit and Sweden’s largest trauma center, was conducted between January 2013 and June 2015. TCK is covering an area with approximately 2.5 million people. More than 1800 trauma cases are treated per year. The majority of patients (80%) are not severely injured (ISS < 15).
Patients receiving fibrinogen concentrate (FC) (RiaSTAP™, CSL Behring, Germany) were included and compared to a control group, that did not receive FC. The control group was matched for age, sex and ISS and was treated at the same hospital during the same time period. See Fig.1 . The primary outcome of the study was mortality, and the secondary outcomes were transfusion volumes, thromboembolic events and organ failure.
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Patients receiving fibrinogen concentrate (FC) (RiaSTAP™, CSL Behring, Germany) were included and compared to a control group, that did not receive FC. The control group was matched for age, sex and ISS and was treated at the same hospital during the same time period. See Fig.
Study design. Inclusion/exclusion criteria and matching criteria of the control group. Patients receiving FC (Fib+), patients not receiving FC (Fib-)
5
Fibrinogen-based Hemostatic Protocols
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Pooled cryoprecipitate was sourced from NHS Blood and Transplant, UK. A commercially available Fg-C, RiaSTAP, was obtained from CSL Behring, Marburg, Germany, and was reconstituted in distilled water (dH2O) according to the manufacturer’s instructions. Both cryoprecipitate and Fg-C were aliquoted and stored at −80 °C. PNP and FDP was obtained from Affinity Biologicals, Ontario, Canada. In some experiments, FDP was used to spike in incremental concentrations of cryoprecipitate or Fg-C. For spiking experiments, the concentration of fibrinogen in Fg-C and cryoprecipitate was determined by Clauss fibrinogen and ELISA and then diluted to the required concentration (0–15 g/L) in dH2O. The same batch of cryoprecipitate and Fg-C was used for all experiments.
6
Comparing Fibrinogen Concentrates and Cryoprecipitate in Trauma Hemorrhage
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Full details of the FEISTY study are available [20 20. Winearls ]. Patients were randomly assigned to receive either Fg-C (Riastap, CSL Behring) or cryo (whole blood or apheresis cryo, Australian Red Cross Lifeblood) replacement during active trauma hemorrhage. All blood samples were collected in 0.13 M trisodium citrate vacutainers and platelet-poor plasma was obtained by centrifugation of whole blood samples at 2500 g for 30 minutes at 4 °C. Plasma samples were stored at -80°C until analysis. Baseline characteristics of the patient cohorts were previously published and included as Supplementary Table S1 [21 21
7
Hemostatic Treatment for Massive Bleeding
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Human fibrinogen concentrate (Riastap®, CSL Behring Marburg, G) and factor XIII (FXIII) concentrate (Fibrogammin®; now registered as Cluvo®, CSL Behring) were dissolved according to the manufacturer’s instructions, giving concentrations of 20 mg/ml and 62.5 IU/ml respectively. 120 μl of fibrinogen concentrate or 120 μl of fibrinogen +15 μl of FXIII were added to the respective blood sample, to a total sample volume of 3000 μl. These dosages correspond to 4 g of fibrinogen and 1550 IU of FXIII to a 70-kg man or 55 mg fibrinogen and 22 IU FXIII per kg of body weight. The FXIII dosage followed recommendations from the manufacturer on how to treat haemorrhage in congenital FXIII-deficient patients (10–20 IU/kg of body weight). The 4 g fibrinogen dosage is in line with current guidelines on treatment of massive bleeding.
8
Evaluating Hemostatic Agent Effects on Blood
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Specified haemostatic agents were added to diluted blood samples for various tests as described as follows. Human fibrinogen concentrate (hFC; RiaSTAP®; CSL Behring, King of Prussia, PA, USA) and cryoprecipitate were added as 5% and 6.25% of the total sample volume. These volumes approximate clinical doses of 4e5 g of hFC 8 and three to four adult pools of cryoprecipitate used to manage severe post-partum haemorrhage. 9 VWF/FVIII concentrate (wilate®; Octapharma AG, Lachen, Switzerland) was added at a final concentration of 1.5 IU ml À1 , corresponding to a 150% increase in FVIII concentration. 10 This preparation of vWF/FVIII contains both FVIII and vWF at a ratio of approximately 1:1. Subsequently, blood samples were tested under the conditions including baseline (control); post-dilution; and post-dilution supplemented with hFC, cryoprecipitate, or vWF/FVIII using the following three assays.
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