scholarly journals Comparison of the New Viscoelastic Coagulation Analyzer ClotPro® With ROTEM® Delta and Conventional Coagulation Tests in Critically Ill Patients With COVID-19

2021 ◽  
Vol 8 ◽  
Author(s):  
Lukas Infanger ◽  
Christoph Dibiasi ◽  
Eva Schaden ◽  
Stefan Ulbing ◽  
Marion Wiegele ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Factor Xa ◽  
Test Results ◽  
Strong Correlations ◽  
Strength Parameters ◽  
Clot Strength ◽  
Viscoelastic Parameters ◽  
Coagulation Testing ◽  
Coagulation Tests

Background: Viscoelastic coagulation testing has been suggested to help manage coagulopathy in critically ill patients with COVID-19. However, results from different viscoelastic devices are not readily comparable. ClotPro® is a novel thromboelastometry analyzer offering a wider range of commercially available assays.Methods: We compared the results from ClotPro with results from the well-established ROTEM® Delta device and conventional coagulation tests in critically ill patients with COVID-19.Results: Viscoelastic parameters indicated the presence of a potentially hypercoagulable state in the majority of patients. In up to 95 paired measurements, we found strong correlations between several parameters routinely used in clinical practice: (i) EX test vs. EXTEM CT, A5, A10, MCF, (ii) IN test vs. INTEM A5, A10, MCF, and (iii) FIB test vs. FIBTEM A5, A10, MCF (all R > 0.7 and p < 0.001). In contrast, IN test CT vs. INTEM CT showed only a moderate correlation (R = 0.53 and p < 0.001). Clot strength parameters of both devices exhibited strong correlations with platelet counts and fibrinogen levels (all R > 0.7 and p < 0.001). Divergent correlations of intrinsically activated assays with aPTT and anti-factor Xa activity were visible. Regarding absolute differences of test results, considerable delta occurred in CT, CFT, and clot strength parameters (all p < 0.001) between both devices.Conclusions: Several parameters obtained by ClotPro show strong correlations with ROTEM Delta. Due to weak correlations of intrinsically activated clotting times and considerable absolute differences in a number of parameters, our findings underline the need for device-specific algorithms in this patient cohort.

Performance of coagulation tests in patients on therapeutic doses of rivaroxaban

2014 ◽  
Vol 111 (06) ◽  
pp. 1133-1140 ◽  
Author(s):  
Emily M. Hawes ◽  
Allison M. Deal ◽  
Dorothy M. Adcock ◽  
Robert Gosselin ◽  
Cheryl Jeanneret ◽  
...  
Keyword(s):  
Factor Xa ◽  
Strong Correlations ◽  
Study Objective ◽  
Drug Levels ◽  
Drug Plasma ◽  
Coagulation Tests ◽  
Trough Blood ◽  
Coagulation Assay ◽  
Drug Plasma Levels ◽  
Therapeutic Doses

SummaryKnowledge of anticoagulation status during rivaroxaban therapy is desirable in certain clinical situations. It was the study objective to determine coagulation tests most useful for assessing rivaroxaban’s anticoagulant effect. Peak and trough blood samples from 29 patients taking rivaroxaban 20 mg daily were collected. Mass spectrometry and various coagulation assays were performed. “On-therapy range” was defined as the rivaroxaban concentrations determined by LC-MS/ MS. A “misprediction percentage” was calculated based on how often results of each coagulation assay were in the normal reference range, while the rivaroxaban concentration was in the “on-therapy” range. The on-therapy range was 8.9 – 660 ng/ml. The misprediction percentages for prothrombin time (PT) and activated partial thromboplastin time (aPTT), using multiple reagents and coagulometers, ranged from 10% – 52% and 31% – 59%, respectively. PT, aPTT and activated clotting time (ACT) were insensitive to trough rivaroxaban: 59%, 62%, and 80% of samples had a normal result, respectively. Over 95% of PT and ACT values were elevated at peak. Four different rivaroxaban calibrated anti-Xa assays had R2 values >0.98, demonstrating strong correlations with rivaroxaban drug levels. In conclusion, PT, aPTT and ACT are often normal in patients on therapeutic doses of rivaroxaban. However, PT and ACT may have clinical utility at higher drug plasma levels. Rivaroxaban calibrated anti-factor Xa assays can accurately identify low and high on-therapy rivaroxaban drug levels and, therefore, have superior utility in all clinical situations where assessment of anticoagulation status may be beneficial.This trial is registered at www.clinicaltrials.gov (#NCT01743898).

Validation of a New Small-Volume Sodium Citrate Collection Tube for Coagulation Testing in Critically Ill Patients with Coagulopathy

2018 ◽  
Vol 64 (06/2018) ◽  
Author(s):  
Elisabeth Adam ◽  
Kai Zacharowski ◽  
Gudrun Hintereder ◽  
Florian Raimann ◽  
Patrick Meybohm
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Sodium Citrate ◽  
Small Volume ◽  
Coagulation Testing ◽  
Collection Tube

scholarly journals Evaluation of coagulation function by rotation thromboelastometry in critically ill patients with severe COVID-19 pneumonia

2020 ◽  
Author(s):  
Vittorio Pavoni ◽  
LARA GIANESELLO ◽  
Maddalena Pazzi ◽  
Caterina Stera ◽  
Tommaso Meconi ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Blood Clot ◽  
Bleeding Risk ◽  
Rotational Thromboelastometry ◽  
Clot Strength ◽  
Vein Thrombosis ◽  
Coagulation Function ◽  
Secondary Hyperfibrinolysis ◽  
Deep Vein

Abstract Critically ill patients with COVID-19 pneumonia suffered both high thrombotic and bleeding risk. The effect of SARS-CoV-2 on coagulation and fibrinolysis is not well known. We conducted a retrospective study of critically ill patients admitted to an intensive care unit (ICU) a cause of severe COVID-19 pneumonia and we evaluated coagulation function using rotational thromboelastometry (ROTEM) on day of admission (T0) and 5 (T5) and 10 (T10) days after admission to ICU. Coagulation standard parameters were also evaluated. Forty patients were enrolled into the study. The ICU and the hospital mortality were 10% and 12.5%, respectively. On ICU admission, prothrombin time was slightly reduced and it increased significantly at T10 (T0=65.1±9.8 vs T10=85.7±1.5, p=0.002), while activated partial thromboplastin time and fibrinogen values were higher at T0 than T10 (32.2±2.9 vs 27.2±2.1, p=0.017 and 895.1±110 vs 332.5±50, p= 0.002, respectively); moreover, whole blood thromboelastometry profiles were consistent with hypercoagulability characterized by an acceleration of the propagation phase of blood clot formation [i.e., CFT below the lower limit in INTEM 16/40 patients (40%) and EXTEM 20/40 patients (50%)] and significant higher clot strength [MCF above the upper limit in INTEM 20/40 patients (50%), in EXTEM 28/40 patients (70%) and in FIBTEM 29/40 patients (72.5%)]; however, this hypercoagulable state persists in the first five days, but it decreases ten day after, without returning to normal values. No sign of secondary hyperfibrinolysis or sepsis induced coagulopathy (SIC) were found during the study period. In six patients (15%) a deep vein thrombosis and in 2 patients (5%) a thromboembolic event, were found; 12 patients (30%) had a catheter-related thrombosis. ROTEM analysis confirms that patients with severe COVID-19 pneumonia had a hypercoagulation state that persisted over time.

scholarly journals Comparison of various principles of coagulation tests in handling hemolysed blood samples

2021 ◽  
Vol 7 (4) ◽  
pp. 188-193
Author(s):  
Dr. Vani Krishnamurthy ◽  
◽  
Rubiya Ahmad ◽  
Keyword(s):  
Prothrombin Time ◽  
Test Results ◽  
Coagulation Test ◽  
Predictive Values ◽  
Background Rejection ◽  
Coagulation Testing ◽  
Coagulation Tests ◽  
The Mean ◽  
Repeat Sampling ◽  
Lost Opportunity

Background: Rejection of hemolysed samples for coagulation test is the standard practice.However, when clinicians deal with extremely sick patients where repeat sampling is difficult toobtain, rejection of the sample is a lost opportunity for the lab physician to assist inpatient care.Proceeding with the test and providing a clinically helpful interpretation of the results will ensure theactive participation of the laboratory physician. Different principles of coagulation testing handle thehemolysed samples differently. It is essential to know the best principle to proceed with thehemolysed sample if need be. This study set out to estimate the predictive values of post-hemolyticsample coagulation test results with various coagulation test principles. Methods: This is aprospective experimental study where the non-hemolysed samples were processed for coagulationtests. Part of the sample was deliberately hemolysed, and the coagulation tests were repeated.Results: Two hundred and forty-eight samples were studied. A median of 11% hemolysis wasachieved experimentally. The mean difference in prothrombin time between pre and post hemolyticsamples with normal PT was 0.9 and with abnormal PT, it was 1.1 seconds. The same for APTT was4.9 and 1.1 seconds, respectively. The majority of the samples showed prolonged coagulation posthemolysis. Positive (PPV) and negative (NPV) predictive values for prothrombin time are 97.3 and73.4%, respectively. Similarly, PPV and NPV for APTT are 97.4 and 47.1%, respectively.Conclusions: Samples with normal values after hemolysis are more likely to be normal.

scholarly journals Standard- versus intermediate-dose enoxaparin for anti-factor Xa guided thromboprophylaxis in critically ill patients with COVID-19

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
David Oliver Hamilton ◽  
Alexander Main-Ian ◽  
Jessie Tebbutt ◽  
Maya Thrasher ◽  
Alicia Waite ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Standard Dose ◽  
Factor Xa ◽  
Apache Ii Score ◽  
Dose Cohort ◽  
Icu Length Of Stay ◽  
The United Kingdom ◽  
Pulmonary Angiogram ◽  
Intermediate Dose

AbstractThe prevalence of venous thromboembolism (VTE) is high in critically ill patients with COVID-19. Dosing of Low Molecular Weight Heparin (LMWH) for thromboprophylaxis in patients with severe COVID-19 is subject to ongoing debate.In this brief report, we describe our study where we retrospectively examined the efficacy of standard- versus intermediate-dosing of enoxaparin in attaining and maintaining accepted prophylactic levels of anti-Factor Xa (anti-FXa) in critically ill patients with COVID-19.We collected data for all patients with confirmed COVID-19 who were treated with enoxaparin for thromboprophylaxis in a single Intensive Care Unit (ICU) in the United Kingdom between 31st March and 16th November 2020. Standard-dose of enoxaparin was 40 mg subcutaneously once daily for patients with normal renal function and body weight between 50 and 100 kg; the intermediate-dose was 40 mg subcutaneously twice daily. Anti-FXa peak concentrations between 0.2-0.4 IU/ml were considered appropriate for thromboprophylaxis.Age, sex, weight, Body Mass Index, APACHE II score, ICU length of stay, initial P/F ratio and creatinine were not statistically significantly different between standard- and intermediate-dose thromboprophylaxis cohorts. In the standard-dose group, the median initial anti-FXa level was 0.13 (interquartile range 0.06-0.18) compared to 0.26 (0.21-0.33) in the intermediate-dose cohort (p < 0.001). On repeated measurement, in the standard dose cohort, 44 of 95 (46%) anti-FXa levels were < 0.2 IU/ml compared with 24 of 132 (18%) levels in the intermediate-dose cohort even after dose-adjustment. There was one radiologically confirmed pulmonary embolism (PE) on computed tomography pulmonary angiogram during hospital admission in each cohort.Our study supports starting intermediate-dose thromboprophylaxis for critically ill patients with COVID-19 to achieve anti-FXa levels in the accepted thromboprophylactic range although further study is required to investigate whether anti-FXa guided thromboprophylaxis is safe and effective in reducing the incidence of VTEs in critically ill patients with COVID-19.

Pathophysiology of disordered coagulation

2016 ◽  
Author(s):  
Simon Stanworth ◽  
Stuart McKechnie
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Thrombin Generation ◽  
Single Gene ◽  
Bleeding Risk ◽  
Bleeding Disorders ◽  
Fibrin Deposition ◽  
Complex Interactions ◽  
Coagulation Tests ◽  
Pro Inflammatory Cytokines

Imbalances in the regulation of haemostasis may manifest as bleeding (depletion of pro-coagulant factors) or thrombosis (deficiency of anti-coagulants). Disordered haemostasis is common in critically-ill patients and may result from infection, trauma, haemorrhage, inflammation, organ dysfunction (notably renal and liver dysfunction), or drug therapy. Complex patterns of coagulopathy where both bleeding and prothrombotic tendencies co-exist are well recognized in critical illness. The limitations of standard laboratory coagulation tests to predict bleeding risk, including activated partial thromboplastin time and prothrombin time, are well recognized. These assays were developed for diagnosis of inherited bleeding disorders or for monitoring of anticoagulant therapy. This has led to increased interest in global haemostatic tests, such as viscoelastic and thrombin generation tests. Thromboembolism is an important cause of morbidity and mortality in critically-ill patients. While inherited causes of bleeding appear to be often related to single gene abnormalities, thrombotic tendencies appear to reflect more complex interactions between inherited and acquired factors. Many interactions exist between coagulation pathways and inflammation. Systemic inflammation triggers widespread activation of coagulation, with pro-inflammatory cytokines activating pro-coagulant pathways and downregulating anticoagulant pathways. A net result of this interaction between inflammatory and coagulation pathways in sepsis is thrombin generation, intravascular fibrin deposition and a consumptive coagulopathy.

Monitoring Treatments with Unfractionated Heparin: CTAD Must Be Used Instead of Citrate as the Anticoagulant Solution When Using Partial-Draw Collection Tubes.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2091-2091
Author(s):  
Pierre A. Toulon ◽  
Lién Abecassis ◽  
Motalib Smahi ◽  
Catherine Ternisien
Keyword(s):  
Unfractionated Heparin ◽  
Platelet Activation ◽  
Conflicts Of Interest ◽  
Vitamin K Antagonists ◽  
Heparin Therapy ◽  
Factor V ◽  
Test Results ◽  
Coagulation Testing ◽  
Coagulation Tests ◽  
Routine Coagulation

Abstract Abstract 2091 Poster Board II-68 Collecting small volumes of blood may be necessary, particularly in pediatrics, or in case of difficult or recurrent sampling. The aim of this multicenter study, involving four hemostasis laboratories, was to compare hemostasis test results in plasma samples obtained using partial- and full-draw evacuated polymer collection tubes containing 0.109 M sodium citrate (1 vol./9 vol.) as the anticoagulant solution (VenoSafeTM, Terumo Europe, Leuven, Belgium). For that purpose, blood was collected into one full- and one partial-draw tube from patients on vitamin K antagonists (VKA, n=100), unfractionated heparin (UFH, n=89), or a low molecular weight derivative (LMWH, n=52), as well as from 136 untreated patients, including 13 hemophiliacs. Routine coagulation tests i.e. PT/INR, aPTT, fibrinogen, and factor V, as well as factor VIII and anti-FXa activity when applicable, were measured using the routine techniques at each participating center. In addition, plasma PF-4 level, evaluated using an ELISA, was investigated in a subset of 36 healthy controls. In untreated patients incl. hemophiliacs as well as in those on either VKA or LMWH, no significantly relevant discrepancy (Bland-Altman) was found between tests results obtained using full- and partial-draw tubes. In contrast, anti-FXa activity in patients on UFH was significantly lower in partial- than in full-draw tubes [median=0.33 IU/mL (range: 0.00-1.11) vs. 0.39 (range: 0.05-1.32) respectively, p<0.0001]. Similarly, aPTT was significantly shorter in partial- than in the full-draw tubes, whereas other test results were not significantly different in the two tubes. That discrepancy was likely to be related to higher amount of PF4 released in plasma after increased platelet activation in partial-draw than in full-draw tubes [392 U/mL (range: 138-971) vs. 177 (range: 52-460) respectively, n=36; p<0.005)]. To further support that hypothesis, blood was collected, from 101 patients on UFH and from 104 untreated patients, into one partial-draw collection tube containing CTAD, a mixture of citrate and inhibitors of platelet activation, as the anticoagulant solution and one full-draw citrated tube, obtained from the same manufacturer. Comparison performed according to Bland-Altman of anti-FXa obtained in the two tubes failed to demonstrate any relevant difference, with a mean bias of +0.02 IU/mL that was identical throughout the measuring range of values [median=0.22 IU/mL (range: 0.06-1.16) vs. 0.20 (range: 0.03-1.15) respectively, n=101]. Moreover, in those patients on UFH, aPTT and other routine coagulation tests were not significantly different in the two tubes and the same applied to test results obtained in the plasma from untreated patients. These results suggest that samples collected into partial-draw citrated tubes allow accurate routine coagulation testing in all patients but those requiring UFH assessment, in which their use could lead to a significant underestimation of anticoagulation. In such cases, partial-draw tubes containing CTAD could be validly used to monitor heparin therapy, as well as to perform routine coagulation testing. Disclosures: No relevant conflicts of interest to declare.

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