Comparison of Higher-Than-Standard to D-Dimer Driven Thromboprophylaxis in Hospitalized Patients With COVID-19

2021 ◽  
pp. 001857872110664
Author(s):  
Maya R. Chilbert ◽  
Collin M. Clark ◽  
Ashley E. Woodruff ◽  
Kimberly Zammit ◽  
Cynthia Lackie ◽  
...  

Introduction: Coronavirus disease 2019 is a global health threat often accompanied with coagulopathy. Despite use of thromboprophylaxis in this population, thrombotic event rates are high. Materials and methods: This was a multicenter, retrospective cohort study comparing the safety and effectiveness of thromboprophylaxis strategies at 2 institutions in hospitalized patients with coronavirus disease 2019. Regimen A utilized a higher-than-standard thromboprophylaxis dosage and Regimen B received full-dose anticoagulation for any D-dimer 3 mcg/mL or greater and prophylactic for less than 3 mcg/mL. The primary outcome compared the rate of thrombotic events between treatment groups. Secondary endpoints compared rates of major or clinically relevant non-major bleeding as well as the proportion of patients in each group experiencing thrombotic events within 30 days of discharge. Results: One-hundred fifty-three patients were included in the analysis, 64 receiving Regimen A and 89 receiving Regimen B. Seven (4.6%) thrombotic events occurred, 3 (4.7%) in patients receiving Regimen A, and 4 (4.5%) in Regimen B ( P = 1.0). Twelve patients (13.5%) receiving Regimen B had a bleeding event versus 2 (3.1%) in Regimen A ( P = .04), half of which were major in each group. All patients who bled in either treatment group were receiving mechanical ventilation, and 12 of 14 were receiving full-dose anticoagulation. One patient receiving Regimen A was readmitted with a pulmonary embolism. Conclusions: In this study, the thromboprophylactic regimen impacted bleeding, but no significant difference was seen with thrombotic outcomes. Almost all patients who experienced a bleed were mechanically ventilated and receiving full-dose anticoagulation. The use of full-dose anticoagulation should be cautioned in this population without an additional indication.

Author(s):  
Fatimah Baqer Alqubbanchi ◽  
Fadya Yaqoob Al-Hamadani

Abstract Background: The novel coronavirus 2 (SARS?CoV?2) pandemic is a pulmonary disease, which leads to cardiac, hematologic, and renal complications. Anticoagulants are used for COVID-19 infected patients because the infection increases the risk of thrombosis. The world health organization (WHO), recommend prophylaxis dose of anticoagulants: (Enoxaparin or unfractionated Heparin for hospitalized patients with COVID-19 disease. This has created an urgent need to identify effective medications for COVID-19 prevention and treatment. The value of COVID-19 treatments is affected by cost-effectiveness analysis (CEA) to inform relative value and how to best maximize social welfare through evidence-based pricing decisions. Objective: compare the clinical outcome and the costs of two anticoagulants (heparin and (enoxaparin)) used to treat hospitalized patients with COVID-19 infection. Patients and method: The study was a retrospective review of medical records of adult, non-pregnant, COVID-19 infected hospitalized patients who had baseline and last outcome measurements at Alamal Epidemiology Center, Al-Najaf city from (Augast 2020 to June 2021). The outcome measures included D-dimer, length of stay (LOS), and mortality rate. Only the cost of the medical treatment was considered in the analysis. The pharmacoeconomics analysis was done in three different cost-effectiveness analysis methods. Microsoft Excel spreadsheet and Statistical Package for the Social Sciences software (SPSS), was used to conduct statistical analysis. Kaplan Meier test was used to compare the mortality rate. T-TEST was used to compare the outcomes of the two groups. Results and discussion: two groups were compared, the first group consists of 72 patients who received heparin, and the second group consists of 72 patients who received enoxaparin. COVID-19 infected patients had a higher abnormal average D-dimer (2534.675 ng/dl). No significant differences between both genders with regards to the basal average D-dimer (males= 2649.95 ng/dl, females= 2374.1mg/dl, P-value>0.05). There was a significant difference between patient's ages 60 years and patients <60. (3177.33 ng/dl, 1763.06 ng/dl, P-value <0.05). It seems that, higher D-dimer levels were associated with a higher mortality rate (died=3166.263 ng/dl, survived= 1729.94 ng/dl, P-value <0.05). Heparin was more effective in decreasing D-dimer levels than enoxaparin which inversely increased the D-dimer levels (-24.4 ng/dl/day, +154.701 ng/dl/day, P-value <0.05). Additionally, heparin was more effective in increasing the survival rate compared to enoxaparin (55% vs, 35%, P-value<0.05). Heparin was associated with a longer duration of stay in hospital than enoxaparin but with no significant difference (13.7 days, 12.3 days, P-value >0.05). Concerning the cost, treatment with heparin cost less than enoxaparin (2.08 U.S $, 9.44 U.S $)/per patient/per day. Conclusion: Originator heparin was a more cost-effective anticoagulant therapy compared to originator enoxaparin, it was associated with a lower cost and better effect, treatment with Heparin resulted in positive INB= 11.3, where a positive result means that heparin is more cost-effective than Enoxaparin. All three methods of pharmacoeconomic analysis decide that heparin was more cost-effective than enoxaparin in treating COVID-19 infected patients.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3535-3535 ◽  
Author(s):  
Alberto F. Sobrero ◽  
Marc Peeters ◽  
Timothy Jay Price ◽  
Yevhen Hotko ◽  
Andres Cervantes-Ruiperez ◽  
...  

3535 Background: The primary analysis of study 20050181 showed that in patients (pts) with wild-type (WT) KRAS mCRC, pmab plus FOLFIRI given as second-line therapy significantly improved progression-free survival (PFS) vs FOLFIRI alone. Here, we report on a prespecified descriptive analysis planned for 30 months (mos) after the last pt was enrolled. Methods: Pts with mCRC, ECOG 0-2, who had one prior fluoropyrimidine-based chemotherapy regimen were randomized 1:1 to pmab 6.0 mg/kg Q2W+FOLFIRI (Arm 1) vs FOLFIRI (Arm 2). Co-primary endpoints were OS and PFS (central assessment). Secondary endpoints included objective response rate (ORR) and safety. Tumor KRAS status was determined by a blinded central lab. Results: 1186 pts were randomised and received tx: 591 in Arm 1, 595 In Arm 2. 1083 pts (91%) had KRAS results. Adverse event rates were consistent with the primary analysis. Results are shown below. Conclusions: In pts with WT KRAS mCRC receiving pmab+FOLFIRI vs FOLFIRI, PFS and ORR were significantly improved, and there was a trend toward improved OS. Post-progression anti-EGFR tx may have attenuated any significant difference in OS between tx arms. In pts with MT KRAS mCRC, no difference in efficacy was observed between tx arms. KRAS testing is critical to select appropriate pts for tx with pmab. [Table: see text]


Author(s):  
Marina Rieder ◽  
Nadine Gauchel ◽  
Klaus Kaier ◽  
Carolin Jakob ◽  
Stefan Borgmann ◽  
...  

Abstract Aims Coagulopathy and venous thromboembolism are common findings in coronavirus disease 2019 (COVID-19) and are associated with poor outcome. Timely initiation of anticoagulation after hospital admission was shown to be beneficial. In this study we aim to examine the association of pre-existing oral anticoagulation (OAC) with outcome among a cohort of SARS-CoV-2 infected patients. Methods and results We analysed the data from the large multi-national Lean European Open Survey on SARS-CoV-2 infected patients (LEOSS) from March to August 2020. Patients with SARS-CoV-2 infection were eligible for inclusion. We retrospectively analysed the association of pre-existing OAC with all-cause mortality. Secondary outcome measures included COVID-19-related mortality, recovery and composite endpoints combining death and/or thrombotic event and death and/or bleeding event. We restricted bleeding events to intracerebral bleeding in this analysis to ensure clinical relevance and to limit reporting errors. A total of 1 433 SARS-CoV-2 infected patients were analysed, while 334 patients (23.3%) had an existing premedication with OAC and 1 099 patients (79.7%) had no OAC. After risk adjustment for comorbidities, pre-existing OAC showed a protective influence on the endpoint death (OR 0.62, P = 0.013) as well as the secondary endpoints COVID-19-related death (OR 0.64, P = 0.023) and non-recovery (OR 0.66, P = 0.014). The combined endpoint death or thrombotic event tended to be less frequent in patients on OAC (OR 0.71, P = 0.056). Conclusions Pre-existing OAC is protective in COVID-19, irrespective of anticoagulation regime during hospital stay and independent of the stage and course of disease. Graphic abstract


2019 ◽  
Vol 37 (2) ◽  
pp. 101-110 ◽  
Author(s):  
Anne Loes van den Boom ◽  
Elisabeth M.L. de Wijkerslooth ◽  
Bas P.L. Wijnhoven

Postoperative antibiotics are recommended after appendectomy for complex appendicitis to reduce infectious complications. The duration of this treatment varies considerably between and even within institutions. The aim of this review was to critically appraise studies on duration of antibiotic treatment following appendectomy for complex appendicitis. A systematic literature search according to the PRISMA guidelines was performed. Comparative studies evaluating different durations of postoperative antibiotic therapy. Primary endpoint was intra-abdominal abscess (IAA) after appendectomy. Secondary endpoints were surgical site infection, readmission and length of hospital stay. The quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. Pooled event rates were calculated using a random-effects model. Nine studies reporting 2006 patients with complex appendicitis were included. The methodological quality of the included articles was poor. IAA was seen in 138 patients (8,6%). Meta-analysis revealed a statistically significant difference in IAA incidence between antibiotic treatment of ≤5 vs. >5 days (risk ratio (OR) 0.36 [95% CI 0.23–0.57] (p < 0.0001)) but not between ≤3 vs. >3 days (OR 0.81 [95% CI 0.38–1.74] (p = 0.59)). Descriptive statistics were used for secondary endpoints. The duration of postoperative antibiotic treatment is not associated with IAA following appendectomy for complex appendicitis.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Sivan Perl ◽  
Marina Bondarenco ◽  
Noam Natif ◽  
Yitschak Shpirer ◽  
Sharon Enghelberg ◽  
...  

Abstract Background Thoracentesis is a low-risk procedure for bleeding (approx. 2%). Data regarding safety of thoracentesis under treatment with clopidogrel is scarce, and current guidelines are not evidence based. We performed a retrospective study to evaluate the rate of bleeding complications of thoracentesis under clopidogrel in hospitalized patients. Methods Retrospective chart review of hospitalized patients undergoing thoracentesis with or without clopidogrel treatment. Demographic and clinical data, diagnostic ICD9 codes, and use of ultrasound were extracted. Bleeding endpoints were defined as hemothorax, drop of > 2 g/dL hemoglobin, or need for packed red cell transfusion. Results The study group comprised of 88 cases and 169 controls. Four bleeding complications were noted in the cases group, versus 5 in the control group (RR 1.53, 95% CI 0.4–5.5). Conclusion Thoracentesis may be performed safely in patients receiving clopidogrel. Bleeding event rates are consistent with previous reports of thoracentesis in general.


Cancers ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1711 ◽  
Author(s):  
Hirokazu Toshima ◽  
Atsushi Hisamatsu ◽  
Kouji Kobayashi ◽  
Hiroo Ishida ◽  
Ken Shimada

Recently, cancer-related venous thromboembolism (VTE) has been termed “cancer-associated thrombosis (CAT)” and is the focus of current research. We retrospectively investigated the efficacy of a single-drug approach with edoxaban for the treatment of non-acute CAT. Thirty-two non-acute CAT patients who received edoxaban were analyzed. The primary endpoint of this analysis was the thrombus disappearance rate at the first evaluation. Secondary endpoints included progression/recurrence of VTE, major bleeding, and D-dimer levels. The thrombus disappearance rate was 62.5%. Therefore, the null hypothesis for the primary endpoint (thrombus disappearance rate of ≤32.0%) was rejected (p = 0.00038) based on the rate of the previous study as the historical control. Recurrent VTE and major bleeding occurred in two patients each. After the start of treatment with edoxaban, a significant difference in D-dimer levels was observed (p = 0.00655). We demonstrated that a single-drug approach with edoxaban is a potential treatment option for non-acute CAT.


Author(s):  
Rushad Patell ◽  
Thita Chiasakul ◽  
Ethan Bauer ◽  
Jeffrey I. Zwicker

Abstract Background Coronavirus disease 2019 (COVID-19) increases thrombosis in hospitalized patients prompting adoption of different thromboprophylaxis strategies. Safety and efficacy of escalated-dose pharmacologic thromboprophylaxis are not established. Objectives To determine the pooled incidence of thrombosis/bleeding in hospitalized patients with COVID-19 for standard-dose, intermediate-dose, therapeutic anticoagulation, and no pharmacologic thromboprophylaxis. Methods MEDLINE, EMBASE, and Cochrane CENTRAL were searched up to August 29, 2020 for studies reporting pharmacologic thromboprophylaxis and thrombosis or bleeding. Pooled event rates were calculated using a random-effects model. Results Thirty-five observational studies were included. The pooled incidence rates of total venous thromboembolism (N = 4,685) were: no prophylaxis 41.9% (95% confidence interval [CI]: 28.1–57.2, I 2 = 76%), standard-dose prophylaxis 19.8% (95% CI: 13.2–28.6, I 2 = 95%), intermediate-dose prophylaxis 11.9% (95% CI: 4.3–28.6, I 2 = 91%), and therapeutic-dose anticoagulants 10.5% (95% CI: 4.2–23.8, I 2 = 82%, p = 0.003). The pooled incidence rates of arterial thrombosis (N = 1,464) were: no prophylaxis 11.3% (95% CI: 5.2–23.0, I 2 = 0%), standard-dose prophylaxis 2.5% (95% CI: 1.4–4.3, I 2 = 45%), intermediate-dose prophylaxis 2.1% (95% CI: 0.5–7.7, I 2 = 45%), and therapeutic-dose anticoagulants 1.3% (95% CI: 0.2–8.8, I 2 = 0, p = 0.009). The pooled bleeding event rates (N = 6,393) were nonsignificantly higher in therapeutic-dose anticoagulants compared with standard-dose prophylaxis, (6.3 vs. 1.7%, p = 0.083). Conclusion Thrombosis rates were lower in hospitalized COVID-19 patients who received pharmacologic thromboprophylaxis. Thrombosis and bleeding rates for patients receiving intermediate-dose thromboprophylaxis or therapeutic anticoagulation were similar to those who received standard-dose pharmacologic thromboprophylaxis.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yin Zhang ◽  
Yu Zhang ◽  
Yuanhong Xu ◽  
Ying Huang

Abstract Objective To identify the correlation between the level of at-admission fasting blood glucose (FBG) with poor outcomes in hospitalized patients suffering from severe fever with thrombocytopenia syndrome (SFTS). Methods Between April 1 and December 1, 2020, the list of hospitalized patients affected with SFTS infection was provided by the Infectious Disease Department at First Affiliated Hospital of Anhui Medical University, followed by the collection of information I.e., gender, age, diabetic history and the level of FBG on admission. Results In this study, a total of 77 patients were included and were categorized into three groups (< 5.6, 5.6–6.9, and ≥ 7.0 mmol/l) on the basis of their glucose level in the blood. The obtained results revealed that among three groups considerable variations were observed in leukocytes, FBG, D-Dimer, aspartate aminotransferase (AST), tumor necrosis factor-α (TNF-α), fibrin degradation products (FDP), and interleukin (IL)-10 level. Correlation analysis indicated a linear negative correlation between PLT and FBG (r = − 0.28, P = 0.01), however, a linear positive correlation was observed between AST, IL10, D-Dimer, and FDP levels and FBG (P-value < 0.05). Multivariate statistical analysis results shown that there was significant difference between group comparison (F = 17.01, P < 0.001) and interaction between group and time (F = 8.48, P < 0.05); but there was no significant difference between time point comparison (F = 0.04, P = 0.96). With the prolongation of time, the changes of FBG were different between survivor group and non-survivor group. The FBG in survival group shown a downward trend; The non-survivor group shown an upward trend. Conclusions Elevated level of FBG has been correlated with hypercoagulability, inflammation, and lower PLT in SFTS patients. The measurement of FBG level can help in evaluating the inflammatory process, hypercoagulability, and prognosis of patients suffering from SFTS. FBG can predict the prognosis of SFTS. It is necessary to pay attention to the role of FBG in the process of treatment in patients with SFTS.


2020 ◽  
Author(s):  
Dr. Animesh Ray ◽  
Dr. Komal Singh ◽  
Souvick Chattopadhyay ◽  
Farha Mehdi ◽  
Dr. Gaurav Batra ◽  
...  

BACKGROUND Seroprevalence of IgG antibodies against SARS-CoV-2 is an important tool to estimate the true extent of infection in a population. However, seroprevalence studies have been scarce in South East Asia including India, which, as of now, carries the third largest burden of confirmed cases in the world. The present study aimed to estimate the seroprevalence of anti-SARS-CoV-2 IgG antibody among hospitalized patients at one of the largest government hospital in India OBJECTIVE The primary objective of this study is to estimate the seroprevalence of SARS-CoV-2 antibody among patients admitted to the Medicine ward and ICU METHODS This cross-sectional study, conducted at a tertiary care hospital in North India, recruited consecutive patients who were negative for SARS-CoV-2 by RT-PCR or CB-NAAT. Anti-SARS-CoV-2 IgG antibody levels targeting recombinant spike receptor-binding domain (RBD) protein of SARS CoV-2 were estimated in serum sample by the ELISA method RESULTS A total of 212 hospitalized patients were recruited in the study with mean age (±SD) of 41.2 (±15.4) years and 55% male population. Positive serology against SARS CoV-2 was detected in 19.8%patients(95% CI 14.7-25.8). Residency in Delhi conferred a higher frequency of seropositivity 26.5% (95% CI 19.3-34.7) as compared to that of other states 8% (95% CI 3.0-16.4) with p-value 0.001. No particular age groups or socio-economic strata showed a higher proportion of seropositivity CONCLUSIONS Around, one-fifth of hospitalized patients, who were not diagnosed with COVID-19 before, demonstrated seropositivity against SARS-CoV-2. While there was no significant difference in the different age groups and socio-economic classes; residence in Delhi was associated with increased risk (relative risk of 3.62, 95% CI 1.59-8.21)


Cephalalgia ◽  
2021 ◽  
pp. 033310242110241
Author(s):  
Shuu-Jiun Wang ◽  
Artemio A Roxas ◽  
Bibiana Saravia ◽  
Byung-Kun Kim ◽  
Debashish Chowdhury ◽  
...  

Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109


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