key: cord-314465-5beuvt8u authors: Hardy, Michaël; Michaux, Isabelle; Lessire, Sarah; Douxfils, Jonathan; Dogné, Jean-Michel; Bareille, Marion; Horlait, Geoffrey; Bulpa, Pierre; Chapelle, Celine; Laporte, Silvy; Testa, Sophie; Jacqmin, Hugues; Lecompte, Thomas; Dive, Alain; Mullier, François title: Prothrombotic Hemostasis Disturbances in Patients with Severe COVID-19: Individual daily data date: 2020-11-10 journal: Data Brief DOI: 10.1016/j.dib.2020.106519 sha: doc_id: 314465 cord_uid: 5beuvt8u This data article accompanies the manuscript entitled: “Prothrombotic Disturbances of Hemostasis of Patients with Severe COVID-19: a Prospective Longitudinal Observational Cohort Study” submitted to Thrombosis Research by the same authors. We report temporal changes of plasma levels of an extended set of laboratory parameters during the ICU stay of the 21 COVID-19 patients included in the monocentre cohort: CRP, platelet count, prothrombin time; Clauss fibrinogen and clotting factors II, V and VIII levels, D-dimers, antithrombin activity, protein C, free protein S, total and free tissue factor pathway inhibitor, PAI-1 levels, von Willebrand factor antigen and activity, ADAMTS-13 (plasma levels); and of two integrative tests of coagulation (thrombin generation ST Genesia) and fibrinolysis (global fibrinolytic capacity - GFC). Regarding hemostasis, we used double-centrifuged frozen citrated plasma prospectively collected after daily performance of usual coagulation tests. Demographic and clinical characteristics of patients and thrombotic and hemorrhagic complications were also collected from patient's electronic medical reports. Corresponding instruments and reagents of laboratory hematology for: platelet count, prothrombin time, Clauss fibrinogen and clotting factors II, V and VIII levels, D-dimers levels, PAI-1 levels, antithrombin activity, protein C activity, free protein S antigen, total and free tissue factor pathway inhibitor antigens, von Willebrand factor antigen and activity, ADAMTS-13 levels), thrombin generation, and global fibrinolytic capacity (GFC); and C-reactive protein. Raw: Public repository Laboratory data: Clinical laboratory tests that describe disturbances of haemostasis of ICU patients, severely affected with CoViD-19: primary haemostasis (platelet count, von Willebrand factor antigen and activity; ADAMTS-13 activity); coagulation (prothrombin time, Clauss fibrinogen, clotting factors II, V and VIII levels, in vitro thrombin potential), natural anticoagulants (antithrombin activity, protein C activity, free protein S antigen, total and free tissue factor pathway inhibitor antigens); and fibrinolysis (D-dimers levels, PAI-1 activity, global fibrinolytic capacity). Clinical data: complications of hemostasis disturbances (thrombosis and hemorrhages) and relevant data for characterization of the cohort (age; sex, BMI, ethnicity, comorbidities, APACHE II, SOFA scores and PaO 2 /FiO 2 ratios at ICU admission, ICU stay duration, anticoagulation regimen, ICU length of stay, need for respiratory, cardiocirculatory or renal support; death). The following laboratory tests were performed with a STA-R Max (Diagnostica Stago, Asnières-sur-Seine) and reagents from Stago: prothrombin time (STA-NeoPTimal), Clauss fibrinogen (STA-Liquid FIB), clotting factor II (STA-NeoPTimal and STA -Deficient II), V (STA-NeoPTimal and STA -Deficient V) and VIII (STA-CK Prest and STA - • The data reported with individual time-courses during the ICU stay show the variability of hemostasis parameters over time and between individuals, suggesting varying thrombotic risks and the need for individualization with frequent reassessment of thrombotic prophylaxis. They can benefit to all physicians and scientists dealing with CoViD-19. • These data will be helpful to design further prospective studies focusing on COVID-19 hemostasis disorders: which parameters to measure and at which frequency. Demographic and clinical characteristics of observed ICU patients are shown in Table 1 . Values correspond to median (with interquartile and min-max ranges) for quantitative data and to number (percent) for qualitative data. Baseline (D0) was defined as ICU admission (in Namur or elsewhere; 11 patients were transferred from the ICU of another Belgian hospital), but the laboratory-monitoring period was restricted to the Namur ICU stay. Tests on D0 were often missing due to delays in patients' inclusion. Table 2 represents the changes over time of hemostasis parameters along ICU stay of 21 severe COVID-19 patients. Observation period has been arbitrarily subdivided into three time-intervals of 10 days starting from D1. For each patient and time-interval, parameters medians were calculated. Medians and interquartile ranges of patient's medians are presented for the three time-intervals. Minimum and maximum values observed are also represented. D-dimers plasma levels are expressed in fibrinogen equivalent units (FEU) and 'reference ranges' depicted correspond to DIC thresholds according to the ISTH definition with the reagents we used [2] . The figures represent the changes over time of measured hemostasis parameters during the ICU stay of each of the 21 patients. Blue lines represent the reference range locally determined, or previously published under similar analytical conditions, or according to the manufacturer's (see figure legends). Stars represent the follow-up period of the patients; orange stars represent the day of diagnosis of a thrombotic complication (which might be delayed form the actual onset). Setting CHU UCL Namur (Godinne site, Yvoir, Belgium), a tertiary academic hospital. All patients admitted to the intensive care unit (ICU) of the CHU UCL Namur for an RT-PCR confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection from March 27 to April 24, 2020 were considered for inclusion. Twenty-one patients were finally included, one patient being excluded because of major therapeutic limitation (i.e.. refusal of tracheal intubation). Patients' characteristics were collected at first ICU admission. Patients were managed according to local standard of care. Anticoagulation guidelines from the Groupe d'Intérêt en Hémostase Périopératoire (GIHP) were implemented in Namur from April 2, 2020 [4] . Patients were screened for deep vein thrombosis (DVT) within a week after Namur ICU admission, and then once a week unless a thrombotic event occurred. Pulmonary embolism (as a matter of fact could be in situ arterial thrombosis) was diagnosed directly by contract CT scan or indirectly by transesophageal ultrasonography (for unstable patients that cannot be transferred safely to the Radiology Department). Bleeding events were defined as minor or major according to ISTH definitions [5] . Blood samples were collected from the arterial line as part of clinical patients' care and at least once a day around 4a.m. Serum was prepared from plastic tubes containing alumina silicate as coagulation activator (Vacuette, Greiner Bio One, Kremsmünster, Austria), whole blood was collected in K2ethylenediaminetetraceatic acid (EDTA) tubes (Vacuette, Greiner Bio One) and plasma was prepared from 109mM citrate tubes (Vacuette, Greiner Bio One) using double centrifugation (1500g, 15min, room temperature). Plasma samples were frozen at -80°C and thawed at 37°C for 5min immediately before analysis. Laboratory tests were performed on 4a.m. samples whenever possible or on the temporally closest samples. CRP levels were measured on a Vitros 5600 Integrated System (Ortho Clinical Diagnostics, Belgium) with CRP Gold Latex reagents (DiAgam, Ghislenghien, Belgium) and platelet count on a Sysmex XN-20 analyzer with Cellpack reagent (Sysmex Corporation, Kobe, Japan). von Willebrand factor antigen 21 LT, lag time; ttP, time to peak, PH, peak height; ETP, endogenous thrombin potential; TFPI, tissue factor pathway inhibitor. The observation was performed in accordance with the Declaration of Helsinki and after approval of the Ethics Committee of the CHU UCL Namur (NUB: B0392020000031). STA-NeoPTimal; expressed as percentage [6]), Clauss fibrinogen (STA-Liquid FIB), clotting factor II (STA-NeoPTimal and STA -Deficient II) Thrombin generation was measured with ST Genesia and STG-ThromboScreen reagent (Stago) after neutralizing heparin with hexadimethrine bromide (25μg/mL; polybrene Global fibrinolytic capacity was measured using the Lysis Timer instrument (Hyphen Biomed ADAMTS-13 activity was measured using the Technozym® ADAMTS-13 Von Willebrand activity was measured with an AcuStar analyser (Instrumentation Laboratory, Bedford, USA) and HemosIL AcuStar VWF:RCo reagent (Instrumentation Laboratory) Some analyses were purposely performed only every 5 days (i.e. vWF antigen and activity, ADAMTS-13, total and free TFPI, tissue-type plasminogen activator) or every other day Prothrombotic Hemostasis Disturbances in Patients with Severe COVID-19: a Prospective Longitudinal Observational Cohort Study A re-evaluation of the D-dimer cut-off value for making a diagnosis according to the ISTH overt-DIC diagnostic criteria: communication from the SSC of the ISTH Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability Prevention of thrombotic risk in hospitalized patients with COVID19 and hemostasis monitoring: Proposals from the French Working Group on Perioperative Haemostasis (GIHP) the French Sdy Group on Thrombosis and Haemostasis (GFHT), in collaboration with the French Society for Anaesthesia and Intensive Care (SFAR) Subcommittee on Control of A. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH Evaluation of a new thromboplastin reagent STA-NeoPTimal on a STA R Max analyzer for the measurement of prothrombin time, international normalized ratio and extrinsic factor levels Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application A new assay for global fibrinolysis capacity (GFC): Investigating a critical system regulating hemostasis and thrombosis and other extravascular functions R: A language and environment for statistical computing The authors would like to thank Professor Bernard Chatelain (Université catholique de Louvain) for providing very sound and helpful advice on the content of the manuscript. The authors would like also to thank Mrs Justine Baudar, Mrs Maité Guldenpfennig and Mr Philippe Devel for performing the experiments and Hyphen Biomed for providing the instrument and reagents for Global Fibrinolytic Activity assay (Lysis Timer). This work was supported by the Belgian Fonds National de la Recherche Scientifique: 'Anticoagulation fibrinolysis COVID19' (reference: 40002796). The authors declare that they have no known competing financial interests or personal relationships that have or could be perceived to have influenced the work reported in this article.