A total of 7 liver xenotransplants (Table 1 ) were performed and grouped as follows: Group 1: bolus administration of Octaplex®, a second-generation human prothrombin complex concentrate (hPCC) containing the coagulation factors II, VII, IX, X and the inhibitors of coagulation, Proteins C and S (generously provided by Octapharma, Lachen, CH) at 2.5 mL/kg (n=2) and a continuous infusion of Octaplex® at 1.0 ml/hr (n=1). Group 2: a continuous infusion of NovoSeven®, recombinant activated Factor VIIa, (Novo Nordisk, Plainsboro, NJ, USA) at 1 mcg/kg/hr (n=3) and further titrated to maintain Factor VII activity to >60%. Group 3: no exogenous coagulation factors (historical control, n=1). For those animals receiving continuous coagulation factors, infusions began six hours following reperfusion of the porcine liver. This latter initiation time was intended to allow for supplementation of baboon circulating factors, with Factor VII having the shortest half-life of all factors (3-6 hours). In addition, the time delay was to also prevent any potential immediate post-transplant graft thrombosis.
Novoseven
Manufactured by Novo Nordisk
Sourced in Denmark
NovoSeven is a recombinant coagulation factor VIIa product used to treat bleeding episodes in patients with hemophilia A or B with inhibitors to factors VIII or IX. It is a lab equipment used in the treatment of bleeding disorders.
Automatically generated - may contain errors
Lab products found in correlation
Feiba, by Baxter (2 mentions)
Novoeight, by Novo Nordisk (1 mentions)
Alteplase, by Genentech (1 mentions)
S 2366, by Werfen (1 mentions)
Spectrozyme fixa, by Sekisui (1 mentions)
S 2765, by Werfen (1 mentions)
S 2302, by Werfen (1 mentions)
Human fxa, by Enzyme Research (1 mentions)
Dade innovin, by Siemens (1 mentions)
11 protocols using novoseven
1
Liver Xenotransplant Coagulation Management
2
Observational Study on rFVIIa for Hemarthrosis in MENA
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The study was an international, prospective, multicentre, observational study conducted in Algeria, Morocco, Oman, Saudi Arabia, and the United Arab Emirates, between October 2010 and April 2012 (ClinicalTrials.gov: NCT01234545). No randomization, stratification, or blinding was performed.
Each participant was observed for 8 months of treatment – beginning with the first bleeding episode reported by the patient – followed by a final visit. To ensure an adequate number of bleeds from a suitable number of patients, patients were withdrawn if no bleed had been registered within 2 months. The maximum duration of the study for each patient was therefore 10 months.
Haemarthrosis was treated with rFVIIa (NovoSeven; Novo Nordisk A/S, Denmark). Two rFVIIa regimens are licensed for the treatment of mild-to-moderate bleeds – 90 μg/kg every 2–3 h, or a single dose of 270 μg/kg. In this observational study, there was no stipulated dosing regimen; the choice of dosing and duration of treatment made entirely at the discretion of the prescribing physician. All details of treatments given were collected, and details of bleeds and where they were managed (at home or elsewhere) were recorded.
Each participant was observed for 8 months of treatment – beginning with the first bleeding episode reported by the patient – followed by a final visit. To ensure an adequate number of bleeds from a suitable number of patients, patients were withdrawn if no bleed had been registered within 2 months. The maximum duration of the study for each patient was therefore 10 months.
Haemarthrosis was treated with rFVIIa (NovoSeven; Novo Nordisk A/S, Denmark). Two rFVIIa regimens are licensed for the treatment of mild-to-moderate bleeds – 90 μg/kg every 2–3 h, or a single dose of 270 μg/kg. In this observational study, there was no stipulated dosing regimen; the choice of dosing and duration of treatment made entirely at the discretion of the prescribing physician. All details of treatments given were collected, and details of bleeds and where they were managed (at home or elsewhere) were recorded.
3
Antibody Screening for BAY 86-6150 Safety
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All bleeding episodes treated with BAY 86-6150 were assessed for safety. Development of neutralizing antibodies to BAY 86-6150 was considered a serious AE that triggered prompt IDMC review.
Screening for anti-BAY 86-6150 antibodies was performed before exposure, after the second exposure, after every fifth exposure, and at study end. Anti-BAY 86-6150 antibodies were determined using a validated enzymelinked immunosorbent assay (ELISA). Samples with positive immunoreactivity on ELISA were further characterized for neutralizing antibody activity using a validated platelet-activated clotting assay. Cross-reactive neutralizing effect on rFVIIa (NovoSeven ® , Novo Nordisk, Bagsvaerd, Denmark) of any detected anti-BAY 86-6150 antibodies was determined using additional functional assays with rFVIIa as the substrate.
Screening for anti-BAY 86-6150 antibodies was performed before exposure, after the second exposure, after every fifth exposure, and at study end. Anti-BAY 86-6150 antibodies were determined using a validated enzymelinked immunosorbent assay (ELISA). Samples with positive immunoreactivity on ELISA were further characterized for neutralizing antibody activity using a validated platelet-activated clotting assay. Cross-reactive neutralizing effect on rFVIIa (NovoSeven ® , Novo Nordisk, Bagsvaerd, Denmark) of any detected anti-BAY 86-6150 antibodies was determined using additional functional assays with rFVIIa as the substrate.
4
Comparative Evaluation of Coagulation Factor Concentrates
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Profilnine SD and Beriplex were purchased from Grifols Biologicals, Inc (Los Angeles, California) and CSL Behring Canada, Inc (Ottawa, Ontario), respectively. Tissue factor, RecombiPlasTin 2G (RCP) was obtained from Instrumentation Laboratory Company (Bedford, Massachusetts). Two batches of NovoSeven were purchased from Novo Nordisk (Copenhagen, Denmark). Seven batches of AryoSeven were obtained from AryoGen (Tehran, Iran). As per the product insert, all AryoSeven products contained 1.2 mg of rFVIIa. The batches of NovoSeven contained 2.4 or 1 mg of rFVIIa. All batches were initially diluted in sterile water to obtain concentrations of 1 mg/mL solution. Further dilutions were made in saline.
5
Concizumab and Hemostatic Agents Evaluation
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6
Spiking Plasma with rFVIIa and PCC
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The mean weight of the overall cohort was used to calculate the amount of rFVIIa to add to plasma to be equivalent to doses of 45, 90 and 180 μg/kg. rFVIIa was purchased from Novonordisk (NovoSeven, Novonordisk, Denmark). The final concentrations of rFVIIa in the spiked plasma were 0.93, 1.85 and 3.7 μg/ml, respectively.
The mean weight of the overall cohort was also used to calculate the amount of PCC to add to plasma equivalent to doses of 25, 35 and 50 U/kg. PCC was a gift from CSL Behring (Beriplex, CSL; Behring UK Ltd, Haywards Heath, UK). The final concentrations of PCC in the spiked plasma were 0.51, 0.72 and 1.03 U/ml, respectively.
The mean weight of the overall cohort was also used to calculate the amount of PCC to add to plasma equivalent to doses of 25, 35 and 50 U/kg. PCC was a gift from CSL Behring (Beriplex, CSL; Behring UK Ltd, Haywards Heath, UK). The final concentrations of PCC in the spiked plasma were 0.51, 0.72 and 1.03 U/ml, respectively.
7
Reversal Agents for DOAC-Induced Bleeding
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Four‐factor PCC (Cofact, Sanquin, Amsterdam, the Netherlands), aPCC (FEIBA, Baxter AG, Vienna, Austria), and rFVIIa (Novoseven, NovoNordisk, Copenhagen, Denmark) were the reversal agents evaluated in this study in the same doses as described in previous work.22 In addition to imitating 80%, 100%, and 125% of the doses suggested for clinical use in case of a major bleeding in a patient treated with a DOAC according to international guidelines23 we also tested the 50% dose for aPCC in the current study. PCC was tested in doses equivalent to 32, 40, and 50 IU/kg, aPCC was tested in doses equivalent to 25, 40, 50 and 62.5 IU/kg and rFVIIa was tested in doses equivalent to 72, 90, and 112.5 μg/kg.
8
Comprehensive Coagulation Protein Assay
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The following materials were obtained from the indicated sources: human fXIa, fIXa, fXa, thrombin, plasma kallikrein, and activated protein C (aPC) (Hematologic Technologies; Essex Junction, VT); recombinant tissue plasminogen activator (tPA) Alteplase® (Genentech; South San Francisco, CA); human α-fXIIa (Enzyme Research Laboratories; South Bend, IL); recombinant factor VIIa (fVIIa) Novoseven® (Novo Nordisk; Bagsværd, Denmark); Lys-plasmin and chromogenic substrates Spectrozyme FVIIa, Spectrozyme FIXa, Spectrozyme PCa, Spectrozyme tPA (Sekisui Diagnostics; Stamford, CT); S-2302, S-2366, S-2765 (Chromogenix; Milano, Italy); and Pefachrome TH 5244 (Pentapharm; Basel, Switzerland). CTI provided by Gamma (Pushchino, Russia) was extracted from corn, purified with ammonium sulfate, acetone precipitation, trypsin-affinity and ion-exchange chromatography, as described previously [17 (link)]. Luffa cylindrica trypsin inhibitor (LCTI-III) was chemically synthesized (Creative Dynamics; Shirley, NY). All other reagents were from (Sigma-Aldrich; St. Louis, MO) unless otherwise noted.
9
Inhibition of FVIIa and FXa by Tick Proteins
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About 0.25 nM FVIIa (NovoSeven; Novo Nordisk) was preincubated with 5 nM TF (Dade Innovin; Siemens) in HN-BSA buffer (20 mM Hepes, 140 mM NaCl, 5 mg/ml BSA, pH 7.4) supplemented with 3 mM CaCl2 for 15 min at 37 °C to allow the formation of the TF–FVIIa complex. After incubating the complex with 0 to 20 μM tick protein for another 15 min at 37 °C, the residual FVIIa activity was probed by adding 0.5 mM Spectrozyme FVIIa (ImmBioMed) and following the absorbance at 405 nm in a plate reader. 0.1 nM human FXa (Enzyme Research Laboratories) in HN-BSA buffer was incubated with 0 to 20 μM tick protein for 15 min at 37 °C. Residual FXa activity was probed by adding 120 μM Biophen CS-11 (65) (Aniara) and following the absorbance at 405 nm.
10
Topical rFVIIa Delivery for Hemostasis
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We dissolved 1 ampule of 1 mg of rFVIIa (NovoSeven; Novo Nordisk A/S, Bagsvaerd, Denmark) in an enclosed 6-mL histidine solution and brought it up to 246 mL with sterile isotonic saline just a few minutes before use. As the carrier, we used a nonwoven abdominal swab (Barrier; Mölnlycke Health Care ApS, Allerød, Denmark) soaked in this solution. The pH of the saline solution was 5.8 and remained unchanged when the swab was soaked into it; thus the presence of the swab did not cause pH changes that could result in the denaturation of rFVIIa.
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