Coagulation Factor Activity in Therapeutic Plasma Prepared from Whole Blood with Pathogen Inactivation (INTERCEPT™) Treatment.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4149-4149
Author(s):  
Jean-Pierre Cazenave ◽  
Hervé Isola ◽  
Marie-Louise Wiesel ◽  
Daniel Kientz ◽  
Michel Laforêt ◽  
...  
Keyword(s):  
Whole Blood ◽  
Total Protein ◽  
Frozen Storage ◽  
Coagulation Factor ◽  
Coagulation Factors ◽  
Blood Collection ◽  
Pathogen Inactivation ◽  
Factor Activity ◽  
Illumination Time ◽  
Frozen Plasma

Abstract Background. A photochemical treatment (PCT) using amotosalen HCl (S-59) and UVA light was developed to inactivate pathogens and leukocytes in therapeutic plasma (INTERCEPT™, I-FFP) frozen within 8 hr of collection. Previous studies demonstrated a broad spectrum of pathogen inactivation (Transfusion2006;46:1168) and clinical efficacy of I-FFP for support of coagulopathies (Transfusion2005;45:1362; Blood2006; 107:3753), and plasma exchange of TTP (Transfusion 2006;46). Preparation of therapeutic plasma from whole blood would complement blood center logistics and reduce the cost of therapeutic frozen plasma provided sufficient coagulation factors were retained. Aims. We measured coagulation factors in plasma isolated from whole blood held overnight at controlled temperature (21 ± 3°C), processed with pathogen inactivation, and frozen within 18 hr of blood collection. Methods. Whole blood units, approximately 460 mL, anticoagulated with CPD (Baxter, La Chatre, France) were drawn from group A, O, B and AB donors. Units were processed after 16 hr storage, and plasma was isolated by centrifugation. Two to 3 plasma units of matched blood group were pooled (n = 30: A = 14, O = 14, B = 1, AB =1) to a final volume of 635 mL. Baseline samples for assay of coagulation factors were withdrawn. Each of 30 pools was mixed with 15 mL of 6 mM amotosalen (150 uM: final concentration) and illuminated with a 3 J/cm2 UVA treatment. Following illumination (~ 8 min) and passage through a flow compound adsorption device (~20 min) to reduce levels of residual S-59, treated plasma units (650 mL) were divided into 3 equal storage units of ≥ 200 mL. Before freezing, post-treatment samples for assay of coagulation factors were withdrawn for assay of coagulation factors. Treated plasma units were flash frozen at -80°C, and transferred to −30°C for 12-month storage. Treated units were withdrawn after 1 month to measure total protein, albumin, IgG, IgM, IgA, fibrinogen, factors II, V, VII, VIII, IX, X, XI, XII, VIII-vWF, Proteins C and S, AT III, plasminogen, alpha-2 antiplasmin, D-dimers, PT, and APTT. Results. Baseline coagulation factor levels (Mean ± SD) were in suitable therapeutic ranges. After PCT, all units had residual platelets < 1×109/L, WBC < 1×104/L, and RBC < 1 × 109/L. After PCT and frozen storage for 1 month, total protein (59 ± 2 g/L), albumin (38 ± 1 g/L), IgG (8.9 ± 1.1g/L), IgA (1.8 ± 0.4 g/L) and IgM (0.9 ± 0.3 g/L) were unchanged from baseline. Mean values for fibrinogen (g/L), coagulation factors (IU/dL), coagulation inhibitors (IU/dL), were variably reduced from baseline, but within ranges defined as suitable for therapeutic plasma (Table). There was no evidence of plasma activation. Conclusions. Plasma prepared from whole blood after storage on cooling plates before processing with the INTERCEPT system for pathogen inactivation retained coagulation factor activity levels after frozen storage (−30°C) in conformance with French national standards for therapeutic frozen plasma (FP). Approximately 36 units (200 mL) could be prepared per hr of illumination time with this system.

Coagulation Factors in Therapeutic Apheresis Plasma Held for 18 Hours at Ambient Temperature Prior to Pathogen Inactivation (INTERCEPT™).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 940-940
Author(s):  
Jean-Pierre Cazenave ◽  
Hervé Isola ◽  
Marie-Louise Wiesel ◽  
Daniel Kientz ◽  
Michel Laforêt ◽  
...  
Keyword(s):  
Ambient Temperature ◽  
Total Protein ◽  
Coagulation Factor ◽  
Coagulation Factors ◽  
Fresh Frozen Plasma ◽  
National Standards ◽  
Activity Levels ◽  
Pathogen Inactivation ◽  
Mean Values ◽  
Frozen Plasma

Abstract Background. A photochemical treatment (PCT) using amotosalen HCl (S-59) and UVA light inactivates pathogens and leukocytes in therapeutic single donor apheresis fresh frozen plasma (INTERCEPT™, I-FFP) prepared within 8 hr of collection. Previous studies demonstrated a broad spectrum of pathogen inactivation (Transfusion2006;46:1168) and clinical efficacy of I-FFP for support of coagulopathies (Transfusion2005;45:1362; Blood2006; 107:3753), and plasma exchange of TTP (Transfusion2006;46). Preparation of therapeutic plasma up to 18 hr after collection would improve production logistics of frozen plasma provided sufficient levels of coagulation factors were retained. Aims. We measured coagulation factors in apheresis plasma stored for 18 hr at ambient temperature, processed with pathogen inactivation, and frozen. Methods. Fifteen jumbo plasma units (650 mL), were collected by apheresis with AB16 anticoagulant from group A, B, AB and O donors (MCS+. Haemonetics, Braintree, MA). Plasma collections were held at ambient blood bank temperature (20 – 24 °C) prior to further processing. After 18 hr, baseline samples for assay of coagulation factors were withdrawn before PCT. Plasma (635 mL plasma) was mixed with 15 mL of 6 mM amotosalen (150 uM: final concentration) and illuminated with a 3 J/cm2 UVA treatment. Following illumination (~ 8 min) and passage through a flow compound adsorption device (~20 min) to reduce levels of residual S-59, treated plasma units (650 mL) were divided into 3 equal storage units of ≥ 200 mL. Before freezing, post-treatment samples were withdrawn for factor assays. Treated plasma units were flash frozen at −80°C, and transferred to −30°C for 12-month storage. Plasma units were withdrawn to measure total protein, albumin, IgG, IgM, IgA, fibrinogen, factors II, V, VII, VIII, IX, X, XI, XII, VIII-vWF, Proteins C and S, AT III, plasminogen, alpha-2 antiplasmin, D-dimers, PT, and APTT. Results. Baseline coagulation factor levels (Mean ± SD) were in therapeutic ranges after 18 hr storage at ambient temperature. After PCT, all units had residual platelets < 1x109/L, WBC < 1x104/L, and RBC < 1 x 109/L. After PCT, total protein (59 ± 4 g/L), albumin (38 ± 2 g/L), IgG (9.0 ± 1.7g/L), IgA (1.6 ± 0.8 g/L) and IgM (0.9 ± 0.5 g/L) were unchanged from baseline. Mean values for fibrinogen (g/L), coagulation factors (IU/dL), coagulation inhibitors (IU/dL) were variably reduced from baseline, but within the ranges defined for therapeutic plasma (Table). Treated plasma showed no evidence of activation. Conclusions. Apheresis plasma held for 18 hr before processing with the INTERCEPT system for pathogen inactivation retained coagulation factor activity levels in conformance with French national standards for therapeutic frozen plasma (FP). Approximately 36 units (200 mL) could be prepared per hr with this system. A single UVA platform is compatible with the operational requirements of a regional blood center producing 12,000 doses (200 mL) of therapeutic FP and 12,000 doses of platelets per year.

scholarly journals Concentrated lyophilized plasma used for reconstitution of whole blood leads to higher coagulation factor activity but unchanged thrombin potential compared with fresh-frozen plasma

Transfusion ◽  
2017 ◽  
Vol 57 (7) ◽  
pp. 1763-1771 ◽  
Author(s):  
Giacomo E. Iapichino ◽  
Martin Ponschab ◽  
Janne Cadamuro ◽  
Susanne Süssner ◽  
Christian Gabriel ◽  
...  
Keyword(s):  
Whole Blood ◽  
Coagulation Factor ◽  
Fresh Frozen Plasma ◽  
Factor Activity ◽  
Fresh Frozen ◽  
Frozen Plasma

Effects of Pathogen Inactivation Using Amotosalen-UVA on Coagulation Parameters in Apheresis and Whole Blood Derived Frozen Plasma in a Large Blood Bank Setting.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 942-942
Author(s):  
Markus M. Mueller ◽  
Hans-Ulrich Pfeiffer ◽  
Margaret Rheinschmidt ◽  
Bernd Poetzsch ◽  
Johannes Oldenburg ◽  
...  
Keyword(s):  
Whole Blood ◽  
Storage Time ◽  
Coagulation Factor ◽  
Blood Bank ◽  
Coagulation Cascade ◽  
Thrombin Time ◽  
Pathogen Inactivation ◽  
Coagulation Parameters ◽  
The Impact ◽  
Frozen Plasma

Abstract Continuous emergence of known or new pathogens as well as increasing complexity of pathogen testing challenge the provision of safe blood products. Pathogen inactivation using amotosalen + UVA effectively reduces a number of different pathogens including viruses, bacteria and parasites (Transfusion2006;46:1168). We determined the impact of pathogen inactivation on the coagulation activity of frozen plasma (FP) using amotosalen (150μM) and UVA (3 J/cm2) in the operational setting of a large blood bank. Plasma (650mL) was collected as single-donor apheresis plasma processed within 8h (arm A) and whole blood derived plasma pooled from three different, but ABO and Rh identical donors after an initial storage time of 8h (arm B) or after 22h (arm C) before photochemical treatment (PCT). Each 650mL unit of treated plasma was divided into 3 units of 200mL each prior to freezing at −40°C. Eight subsequent FP units (200mL) from individual collections were analyzed per arm, representing different blood groups. Samples for coagulation analysis were taken at baseline, after PCT and absorption of amotosalen (post-inactivation), and after six weeks of storage at −40°C (post-storage). Global coagulation tests (PT, aPTT), thrombin time, fibrinogen activity (Clauss) and fibrinogen antigen levels remained within normal ranges at all time points in all three arms. Similarly, activities of coagulation factors II, V, VII, IX, X, XI, XII, XIII, as well as von Willebrand factor (vWF) antigen, ristocetin cofactor, vWF-collagen binding capacity, antithrombin, protein C levels, protein S activity, plasmin-antiplasmin-complexes (PAP), plasminogen levels, and D-dimers did not show significant alterations. Median factor VIII activities were diminished compared to baseline (= 100%) in all three groups post-inactivation and post-storage, respectively (A: 84% and 80%; B: 74% and 65%; C: 84% and 93%). Significant differences in thrombin-antithrombin-complex (TAT) levels were seen between apheresis plasma (< 0.1 ng/ml) and plasma processed from whole blood after 8h (7.25 ng/ml) and 22h (57 ng/ml) of storage time prior to PCT. During pathogen inactivation, there was no increase in TAT levels ruling out that thrombin was formed through the inactivation process. In summary, pathogen inactivation of FP using amotosalen + UVA does not significantly influence coagulation parameters with the exception of FVIII. The decrease in FVIII activity might be explained in part by an additional freeze-thawing cycle included in the protocol due to technical reasons. Increased TAT levels, especially in arm C, were not reflected in decreased AT activity or an increase in other markers of coagulation activation, but indicate continuous, although moderate activation of the coagulation cascade during storage time. We conclude that the described inactivation procedure for whole blood derived and apheresis FP can be performed in a large blood bank setting without significant decreases in coagulation factor activities and thus without major impairment of the functional capacity of therapeutic plasma.

Validation Studies in European Blood Centers To Evaluate Processing Whole-Blood-Derived or Apheresis Plasma Using the INTERCEPT Blood System Intended for Commercialization.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 957-957
Author(s):  
Y. Singh ◽  
T. Hervig ◽  
P. Schlenke ◽  
J.P. Cazenave ◽  
L. Pinkoski ◽  
...  
Keyword(s):  
Whole Blood ◽  
Validation Studies ◽  
Coagulation Factor ◽  
Operating Conditions ◽  
Reference Laboratory ◽  
Pathogen Inactivation ◽  
Factor Activity ◽  
Phase 3 ◽  
Baseline Activity ◽  
Pre Treatment

Abstract Introduction: INTERCEPT plasma (I-FFP) for transfusion is prepared with a photochemical treatment (PCT) system using amotosalen (S-59) and long-wavelength UVA light to inactivate a broad spectrum of blood-borne pathogens. For Phase 3 clinical trials, 6 US blood centers prepared an inventory of ~10,000 I-FFP units by processing ~250 mL whole blood-derived (WB) or apheresis (APH) plasma units using a prototype PCT system. In these trials, I-FFP effectively supported patients with congenital and acquired coagulopathies or TTP. The prototype PCT system has been modified to treat up to 635 mL of plasma in a single PCT process, yielding up to three ~200 mL doses while maintaining pathogen inactivation efficacy. This modified PCT system intended for commercialization was evaluated in process validation studies in 3 European blood centers under routine operating conditions. After processing with the commercial PCT system, the effect on coagulation factor activity and retention was assessed in APH plasma (Blood2004;104:746a) and, as reported here, in WB plasma. Methods: Whole blood and/or APH plasma units were collected at 3 European blood centers. Three-unit pools (~600 mL) of WB plasma were prepared. APH plasma (~600 mL) was collected using Autopheresis C (Baxter) or MCS+(Haemonetics) devices. Blood bank personnel processed a total of 60 WB plasma pools and 90 APH plasma units using the commercial PCT system. Baseline and I-FFP plasma samples were collected, frozen below -60°C, and sent to Cerus for assay of factors I (fibrinogen), II, V, VII, VIII, IX, X, XI, and XIII, proteins C (PC) and S (PS), and antithrombin III (AT). Alpha-2 antiplasmin (AP) was assayed by a reference laboratory. Comparative data from a representative subset of I-FFP units prepared for the Phase 3 trials using the prototype PCT system were obtained from samples collected during PCT processing and stored at ≤−70°C. Retention of activity is expressed as the proportion (%) of pre-treatment (baseline) activity remaining after PCT. Results: Retention of coagulation factor activity in WB and APH I-FFP prepared with the commercial PCT system (Comm) was 73–76% of baseline fibrinogen and FVIII activity, and 80–97% of baseline for factors II, V, VII, IX, X, XI, XIII, PC, PS, AT, and AP (Table). Retention of activity in I-FFP prepared with the commercial PCT system was similar to that of I-FFP prepared with the clinical prototype. Conclusion: The PCT system intended for commercialization provides multiple I-FFP doses with a single PCT process. Retention of coagulation factor activity in WB and APH plasma processed with the commercial PCT system was similar to that of I-FFP used in Phase 3 trials to effectively support patients with congenital and acquired coagulopathies or TTP. Retention of Coagulation Factor Activity in I-FFP

Stability of antioxidant vitamins in whole human blood during overnight storage at 4°C and frozen storage up to 6 months

2018 ◽  
Vol 88 (3-4) ◽  
pp. 151-157 ◽  
Author(s):  
Scott W. Leonard ◽  
Gerd Bobe ◽  
Maret G. Traber
Keyword(s):  
Ascorbic Acid ◽  
Whole Blood ◽  
Healthy Subjects ◽  
Frozen Storage ◽  
Blood Collection ◽  
Plasma Samples ◽  
Optimal Conditions ◽  
Plasma Ascorbic Acid ◽  
Blood Samples ◽  
Sample Handling

Abstract. To determine optimal conditions for blood collection during clinical trials, where sample handling logistics might preclude prompt separation of erythrocytes from plasma, healthy subjects (n=8, 6 M/2F) were recruited and non-fasting blood samples were collected into tubes containing different anticoagulants (ethylenediaminetetra-acetic acid (EDTA), Li-heparin or Na-heparin). We hypothesized that heparin, but not EDTA, would effectively protect plasma tocopherols, ascorbic acid, and vitamin E catabolites (α- and γ-CEHC) from oxidative damage. To test this hypothesis, one set of tubes was processed immediately and plasma samples were stored at −80°C, while the other set was stored at 4°C and processed the following morning (~30 hours) and analyzed, or the samples were analyzed after 6 months of storage. Plasma ascorbic acid, as measured using HPLC with electrochemical detection (LC-ECD) decreased by 75% with overnight storage using EDTA as an anticoagulant, but was unchanged when heparin was used. Neither time prior to processing, nor anticoagulant, had any significant effects upon plasma α- or γ-tocopherols or α- or γ-CEHC concentrations. α- and γ-tocopherol concentrations remained unchanged after 6 months of storage at −80°C, when measured using either LC-ECD or LC/mass spectrometry. Thus, refrigeration of whole blood at 4°C overnight does not change plasma α- or γ-tocopherol concentrations or their catabolites. Ascorbic acid is unstable in whole blood when EDTA is used as an anticoagulant, but when whole blood is collected with heparin, it can be stored overnight and subsequently processed.

Acquired Multiple Coagulation Factor Inhibitors Associated Bleeding Disorder

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4511-4511
Author(s):  
Qin-fen Chen ◽  
Pei Li ◽  
Yi Xie ◽  
Bao-An Chen
Keyword(s):  
Plasma Exchange ◽  
Immunosuppressive Agents ◽  
Clinical Manifestations ◽  
Coagulation Factor ◽  
Coagulation Factors ◽  
Bleeding Disorder ◽  
Thrombin Time ◽  
Beneficial Effects ◽  
First Case ◽  
Frozen Plasma

Abstract Objective: To inquire into the clinical features of acquired multiple coagulation factors inhibitors associated bleeding disorder. Methods: A case of acquired multiple coagulation factors inhibitors in clinical manifestations, diagnosis, treatment and result was described and related literatures were reviewed. Results: A 74-year-old man developed sustained wound bleeding after implantation of heart pacemaker. Prothrombin time (PT), activated partial thromboplastin time (APTT) were prolonged significantly. But thrombin time (TT), fibrinogen (Fg), platelet count(PLT) and liver function were normal. 3P test was negative. Further tests revealed that the activities of factor 2, 5, 7,8,9,10,11,12 were all less than 10%, and the inhibitors of these factors could be detected, with the titers ranging from 8~64 Bu. So acquired multiple coagulation factor inhibitors was diagnosed. Transfusion with frozen plasma and cryoprecipitate was ineffective, whereas the combination therapy with glucocorticoid plus plasma exchange seemed to be successful. The patient was cured. Conclusion: Acquired multiple coagulation factors inhibitors is a rare bleeding disorder. In fact, this is the first case, as far as we are aware. It may develop serious bleeding. Immunosuppressive agents, such as corticosteroids, used for suppression of autoantibodies formation and plasma exchange, used for eradication of inhibitors may have beneficial effects.

Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies

Transfusion ◽  
2005 ◽  
Vol 45 (8) ◽  
pp. 1362-1372 ◽  
Author(s):  
Pedro De Alarcon ◽  
Richard Benjamin ◽  
Marion Dugdale ◽  
Craig Kessler ◽  
Rinah Shopnick ◽  
...  
Keyword(s):  
Coagulation Factor ◽  
Fresh Frozen Plasma ◽  
Pathogen Inactivation ◽  
Fresh Frozen ◽  
Frozen Plasma

scholarly journals Stability of Thawed Apheresis Fresh-Frozen Plasma Stored for up to 120 Hours at 1°C to 6°C

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
William P. Sheffield ◽  
Varsha Bhakta ◽  
Qi-Long Yi ◽  
Craig Jenkins
Keyword(s):  
Prothrombin Time ◽  
Closed System ◽  
Whole Blood ◽  
Coagulation Factors ◽  
Fresh Frozen Plasma ◽  
Refrigerated Storage ◽  
Fresh Frozen ◽  
Frozen Plasma ◽  
Over Time ◽  
Made In

Regulations concerning the storage of transfusable plasma differ internationally. In Canada, plasma obtained from whole blood donations and frozen within 24 hours of phlebotomy (frozen plasma, FP) may be thawed and transfused within 120 hours of refrigerated storage. However, plasma frozen within 8 hours of phlebotomy following apheresis donation (FFPA) must be transfused within 24 hours of thawing and refrigeration. Our objectives were to measure coagulation factors (F) V, VII, and VIII, fibrinogen activities, and the prothrombin time (PT) in thawed refrigerated FFPA at 0, 24, and 120 hours of storage and to compare these values to those in thawed refrigerated FP. Fibrinogen activity remained unchanged over time, while mean factor levels in 28 FFPA units declined by 17% (FV), 19.7% (FVII), and 54.6% (FVIII) over 120 hours, while PT values rose to 7.6%. Factor activities were significantly higher in FFPA than FP after 120 hours of refrigerated storage. Residual FVIII activities in thawed FFPA met predefined noninferiority criteria compared to thawed FP after 120 hours. These results support a change in Canadian regulations to permit transfusion of thawed FFPA made in a closed system and refrigerated for up to 120 hours, one that could reduce wastage of transfusable plasma.

scholarly journals Effects of Storage Time on Total Protein and Globulin Concentrations in Bovine Fresh Frozen Plasma Obtained for Transfusion

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
D. Proverbio ◽  
E. Spada ◽  
L. Baggiani ◽  
G. Bagnagatti De Giorgi ◽  
N. Roggero ◽  
...  
Keyword(s):  
Total Protein ◽  
Storage Conditions ◽  
Fresh Frozen Plasma ◽  
Blood Collection ◽  
Bovine Plasma ◽  
Fresh Frozen ◽  
Fresh Plasma ◽  
Beta 2 ◽  
Mean Concentration ◽  
Frozen Plasma

To evaluate the effects of storage conditions on total protein (TP) and globulin fractions in fresh frozen bovine plasma units prepared and stored for transfusion, TP and globulin fractions were evaluated in fresh plasma and at 1 month and 6 and 12 months after blood collection in plasma stored at −20°C. Significant differences in concentrations were found in the median concentration of total protein (P=0.0336), between 0 months and 1 month (P=0.0108), 0 and 6 months (P=0.0023), and 0 and 12 months (P=0.0027), in mean concentration (g/dL) of albumin (P=0.0394), between 0 months and 1 month (P=0.0131), 0 and 6 months (P=0.0035), and 0 and 12 months (P=0.0038), and beta-2 fraction (P=0.0401), between 0 and 6 months (P=0.0401) and 0 and 12 months (P=0.0230). This study suggests that total gamma globulin concentration in bovine frozen plasma is stable for 12 months at −20°C. Total protein, ALB, and beta-2 fraction have significantly different concentrations (g/dL) when compared to prestorage. This study has shown IgG protein fraction stability in bovine fresh frozen plasma collected for transfusion; therefore, bovine fresh frozen plasma seems to be suitable for the treatment of hypogammaglobulinemia (failure of passive transfer) in calves when stored for 12 months at −20°C.

scholarly journals Coagulation profile of human COVID-19 convalescent plasma

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Allan M. Klompas ◽  
Noud van Helmond ◽  
Justin E. Juskewitch ◽  
Rajiv K. Pruthi ◽  
Matthew A. Sexton ◽  
...  
Keyword(s):  
Coagulation Factor ◽  
Protein S ◽  
Coagulation Factors ◽  
Fresh Frozen Plasma ◽  
Thrombin Time ◽  
Fresh Frozen ◽  
Von Willebrand ◽  
Willebrand Factor ◽  
Plasmin Inhibitor ◽  
Frozen Plasma

AbstractConvalescent plasma is used to treat COVID-19. There are theoretical concerns about the impact of pro-coagulant factors in convalescent plasma on the coagulation cascade particularly among patients with severe COVID-19. The aim of this study was to evaluate the coagulation profile of COVID-19 convalescent plasma. Clotting times and coagulation factor assays were compared between fresh frozen plasma, COVID-19 convalescent plasma, and pathogen-reduced COVID-19 convalescent plasma. Measurements included prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, D-dimer, von Willebrand factor activity, von Willebrand factor antigen, coagulation factors II, V, VII–XII, protein S activity, protein C antigen, and alpha-2 plasmin inhibitor. Clotting times and coagulation factor assays were not different between COVID-19 convalescent plasma and fresh frozen plasma, except for protein C antigen. When compared to fresh frozen plasma and regular convalescent plasma, pathogen reduction treatment increased activated partial thromboplastin time and thrombin time, while reducing fibrinogen, coagulation factor II, V, VIII, IX, X, XI, XII, protein S activity, and alpha-2 plasmin inhibitor. The coagulation profiles of human COVID-19 convalescent plasma and standard fresh frozen plasma are not different. Pathogen reduced COVID-19 convalescent plasma is associated with reduction of coagulation factors and a slight prolongation of coagulation times, as anticipated. A key limitation of the study is that the COVID-19 disease course of the convalesced donors was not characterized.

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