scholarly journals 133 Incidence of Imaging Confirmed Stroke and Thrombotic Events in Older Adults with Severe COVID-19 Infection

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
L Hickmott ◽  
C Jeyarajah ◽  
S Logarajah ◽  
A Webber ◽  
D Epstein ◽  
...  
Keyword(s):  
Older Adults ◽  
Ischaemic Stroke ◽  
Acute Stroke ◽  
Sinus Thrombosis ◽  
Local Population ◽  
Thrombotic Event ◽  
Clinical Signs ◽  
Cerebral Haemorrhage ◽  
Increased Risk ◽  
D Dimer

Abstract   During the initial phase of the response to COVID-19, concern was raised regarding a potential link with increased risk of stroke. We aimed to explore the incidence of stroke and thrombotic events within our local population with COVID-19 infection who required admission to the Intensive Care Unit (ICU). Methods Retrospective analysis of 57 consecutive patients with a diagnosis of COVID-19 infection admitted to Barnet General Hospital ICU between 6th March and 26th April 2020. Cases were reviewed to establish whether there had been imaging (CT or MRI) confirmed ischaemic stroke, intra-cerebral haemorrhage (ICH), venous sinus thrombosis (VST) or other thrombotic event, including pulmonary embolism (PE). Data was collected on baseline characteristics and blood tests including D-Dimer levels. Statistical analysis was performed using two-tailed t-test and Fischer’s exact test (FET). Findings: Nineteen patients (33%) were age 65 years or older (mean age 69, range 65 to 74 years) and of these 2 patients (10.5%) had imaging confirmed acute ischaemic stroke. In those under 65 (mean age 54, range 29–64 years) there was one confirmed ICH and one VST. The incidence of PE was 21% in both groups. Survival was significantly lower in the age 65 or older group (26.3% versus 63.2%, p = 0.0119 (FET)). Peak recorded D-Dimer levels also appeared to be significantly higher in the age 65 or older group (p = 0.0003, 95% CI 13068.89 to 39858.68). Conclusions and limitations These findings highlight the importance of awareness of risk of thrombotic events, including acute stroke, in older adults with severe Covid-19 infection. It is possible that the incidence of stroke was underestimated, including due to challenges identifying clinical signs of acute stroke and safely obtaining imaging in this population. Further, ideally prospective, studies are required to more clearly elucidate the degree of association between COVID-19 infection and stroke and VST.

scholarly journals A Systematic Review and Meta-Analysis of Molecular Biomarkers Associated with Early Neurological Deterioration Following Acute Stroke

2018 ◽  
Vol 46 (5-6) ◽  
pp. 230-241 ◽  
Author(s):  
Alexander J. Martin ◽  
Christopher I. Price
Keyword(s):  
Ischaemic Stroke ◽  
Acute Stroke ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Density Lipoprotein ◽  
High Sensitivity ◽  
Neurological Status ◽  
Neurological Deterioration ◽  
Increased Risk ◽  
Early Neurological Deterioration

Background: Early neurological deterioration (END) following acute stroke is associated with poorer long-term outcomes. Identification of patients at risk could assist early monitoring and treatment decisions. This review summarised the evidence describing non-radiological biomarkers for END. Summary: Electronic searches from January 1990 to March 2017 identified studies reporting a blood/cerebrospinal fluid (CSF)/urine biomarker measurement within 24 h of acute stroke and at least 2 serial assessments of clinical neurological status (< 24 h and < 7 days). Out of 12,895 citations, 82 studies were included, mostly focusing on ischaemic stroke. Using higher neurological thresholds, the n-weighted END incidence for ischaemic stroke was 11.9% (95% CI 11.4–12.4%) and 18.6% (17.9–19.2%) for lower thresholds. Incidence decreased with advancing study publication year (Pearson r-squared 0.23 and 0.15 for higher and lower threshold studies). After classification into 3 broad categories, meta-analysis showed that biomarkers associated with increased END risk (n; fixed-effects mean difference; 95% CI) were “metabolic” (glucose [n = 9,481; 0.90 mmol/L; 0.74–1.06], glycosylated haemoglobin [n = 3,146; 0.33%; 0.19–0.46], low-density lipoprotein [n = 4,839; 0.13 mmol/L; 0.06–0.21], total cholesterol [n = 4,762; 0.21 mmol/L; 0.11–0.31], triglycerides [n = 4,820; 0.11 mmol/L; 0.06–0.17], urea [n = 1,351; 0.55 mmol/L; 0.14–0.96], decreasing albumin [n = 513; 0.33 g/dL; 0.05–0.61]); “inflammatory and excitotoxic” (plasma glutamate [n = 688; 60.13 µmol/L; 50.04–70.22], CSF glutamate [n = 369; 7.50 µmol/L; 6.76–8.23], homocysteine [n = 824; 2.15 µmol/L; 0.68–3.61], leucocytes [n = 3,766; 0.54 × 109/L; 0.34–0.74], high-sensitivity C-reactive protein [n = 1,707; 3.79 mg/L; 1.23–6.35]); and “coagulation/haematological” (fibrinogen [n = 3,132; 0.32 g/L; 0.25–0.40]; decreasing haemoglobin [n = 3,586; 2.38 g/L; 0.15–4.60]). Key Messages: Declining incidence of END may represent improving care standards; however, it remains a frequent occurrence. Although statistical associations exist between biomarkers and an increased risk of END, the most promising still need prospective evaluation to determine their additional value relative to baseline radiological and clinical characteristics.

scholarly journals Markers Of Coagulation And Hemostatic Activation Identify COVID-19 Patients At High Risk For Thrombotic Events, ICU Admission and Intubation

2020 ◽  
Author(s):  
Darwish Alabyad ◽  
Srikant Rangaraju ◽  
Michael Liu ◽  
Rajeel Imran ◽  
Christine L. Kempton ◽  
...  
Keyword(s):  
Thrombotic Event ◽  
Anticoagulation Therapy ◽  
Vascular Events ◽  
Icu Admission ◽  
Vein Thrombosis ◽  
Coagulation Marker ◽  
Increased Risk ◽  
Patients At Risk ◽  
Deep Vein ◽  
D Dimer

ABSTRACTBackgroundCoronavirus disease 2019 (COVID-19) has been associated with a coagulopathy giving rise to venous and arterial thrombotic events. The objective of our study was to determine whether markers of coagulation and hemostatic activation (MOCHA) on admission could identify COVID-19 patients at risk for thrombotic events and other complications.MethodsCOVID-19 patients admitted to a tertiary academic healthcare system from April 3, 2020 to July 31, 2020 underwent standardized admission testing of MOCHA profile parameters (plasma d-dimer, prothrombin fragment 1.2, thrombin-antithrombin complex, and fibrin monomer) with abnormal MOCHA defined as ≥ 2 markers above the reference. Prespecified thrombotic endpoints included deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, and access line thrombosis; other complications included ICU admission, intubation and mortality. We excluded patients on anticoagulation therapy prior to admission and those who were pregnant.ResultsOf 276 patients (mean age 59 ± 6.4 years, 47% female, 62% African American race) who met study criteria, 45 (16%) had a thrombotic event. Each coagulation marker on admission was independently associated with a vascular endpoint (p<0.05). Admission MOCHA with ≥ 2 abnormalities (n=203, 74%) was associated with in-hospital vascular endpoints (OR 3.3, 95% CI 1.2-8.8), as were admission D-dimer ≥ 2000 ng/mL (OR 3.1, 95% CI 1.5-6.6), and admission D-dimer ≥ 3000 ng/mL (OR 3.6, 95% CI 1.6-7.9). However, only admission MOCHA with ≥ 2 abnormalities was associated with ICU admission (OR 3.0, 95% CI 1.7-5.2) and intubation (OR 3.2, 95% CI 1.6-6.4), while admission D-dimer ≥2000 ng/mL and admission D-dimer ≥ 3000 ng/mL were not associated. MOCHA and D-dimer cutoffs were not associated with mortality. Admission MOCHA with <2 abnormalities (26% of the cohort) had a sensitivity of 88% and negative predictive value of 93% for a vascular endpoint.ConclusionsAdmission MOCHA with ≥ 2 abnormalities identified COVID-19 patients at increased risk of ICU admission and intubation during hospitalization more effectively than isolated admission D-dimer measurement. Admission MOCHA with <2 abnormalities identified a subgroup of patients at low risk for vascular events. Our results suggest that an admission MOCHA profile can be useful to risk-stratify COVID-19 patients.

scholarly journals Cerebral venous thrombosis secondary to an occult maxillary sinusitis in a young male from sub-Saharan Africa

2019 ◽  
pp. 08-12
Author(s):  
Mazou N Temgoua ◽  
Mickael Essouma ◽  
Larry N Tangie ◽  
Cedric Tsinda ◽  
Drusille Feze Foko ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Acute Stroke ◽  
Cerebral Venous Thrombosis ◽  
Fungal Infections ◽  
Sinus Thrombosis ◽  
Maxillary Sinusitis ◽  
Case Reports ◽  
Sub Saharan Africa ◽  
First Case ◽  
Increased Risk

Cerebral venous thrombosis (CVT) also termed cerebral venous sinus thrombosis (CVST), is a special type of cerebrovascular disease characterized by cerebral venous infarction [1]. As from 1825 when the first case was described by Ribes[2], epidemiological descriptions are still restricted to case reports and small retrospective cross-sectional studies yielding low butincreasing incidence: <10 cases per million per year in 1995 to about 13.2 cases per million per year in 2012.CVT mainly occurs in women of child bearing age, probably owing to the use of oral contraceptive pills, and mostly has an acute or subacute course [1]. It can be categorized as primary/idiopathicand secondary. Secondary CVT can further be classified into infective (mainly due to bacterial or fungal infections) and non-infective CVT; the latterbeing due tocoagulation disorders, neoplasms, procoagulant hemodynamic states, vascularitis,homocystinuria, or head trauma [3].With the advent of antibiotics, the epidemiology of CVT has shifted from predominant infective CVT to predominant non-infective CVT, leading to increased risk of misdiagnosis and delayed treatment [3]. We report occult purulent maxillary sinusitis-related CVT in a male Cameroonian patient who presented with headaches, seizures and acute stroke syndrome. The aim of this paper is to reiterate CVT as the main cause of acute stroke syndrome in young adults irrespective of ethnic origin and sex, and suggest systematic screening of infections in those patients, especially in regions with high rates of infections likesub-Saharan Africa.We describe this case with regard to CARE guidelines.

scholarly journals Low Rate of Thrombosis in Mexican Patients with COVID-19 Infection. a Benefit of Higher Doses Anticoagulants or a Sub Diagnosis?

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Félix Gibrant Marquez ◽  
Santiago Riviello-Goya ◽  
Angel Gabriel Vargas Ruiz ◽  
Edgar Ortíz Brizuela ◽  
Fernando Gil López ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Venous Thrombosis ◽  
Critically Ill ◽  
Major Bleeding ◽  
Thrombotic Event ◽  
Factors Associated ◽  
Increased Risk ◽  
Critical Patients ◽  
D Dimer ◽  
Low Rate

Background: Patients with COVID-19 have an increased risk of thromboembolic disease, this has been partly attributed to an excessive inflammatory response that is associated with hypercoagulability; patients develop thrombotic complications with rates of 6.4% in non-critically ill and 15 to 31 % in critically ill patients. With this data some clinicians have incorporated thromboprophylaxis with higher dose heparin into the management of this patients, to date there´s no information of the effect of this intervention. Methods: We conducted a prospective cohort, including consecutive critical and non-critical adults admitted to a referral center in Mexico City, between March 18 and May 19, all with a positive RT-PCR for SARS-CoV 2. Conventional coagulation test results were collected on admission and during hospitalization; use of anticoagulation, and patient outcomes were recorded, all patients had been discharged at the time of the final analysis. Thromboprophylaxis was administered according to institutional recommendations and individual medical criteria, we defined anticoagulant dose according to each medication. We compared the basal characteristics and outcomes in critical and non-critical patients. We evaluated the factors associated with thrombosis, bleeding, and mortality using the Cox Regression Model. Results: We evaluated 447 consecutive hospitalized patients with COVID-19, median age was 50 years (range,18-91), 62.6 % were male, 111 (24.8%) were critical. At admission 156 patients (34.9%) had D-dimer values above 3000 ng/mL, median fibrinogen was 651 mg/dL (range 130-1095), APTT was prolonged (&gt; 3 seconds) in 179 patients (40%), and INR &gt;1.2 in 26 patients (5.8%), median platelet value 215 X103/uL (range 33-666). Thromboprophylaxis' dosages were prophylactic in 267 (59.7%), intermediate in 75 (16.8%) and therapeutic in 91 (20.4%), 14 patients (3.1%) did not receive any medical thromboprophylaxis and 26 patients (5.8%) received aspirin during hospitalization. According to the International Society on Thrombosis and Hemostasis' criteria (ISTH criteria) 40 patients (8.9%) had overt-DIC, sepsis induced coagulopathy (SIC) was present in 28 patients (6.3%), and high risk for bleeding by IMPROVE score ≥7 points was found in 5 patients (1.1%). Overall thrombotic event (TE) was confirmed in five patients (1.1%), arterial thrombosis events in 0.4%, one stroke and one acute myocardial infarction; radiographically confirmed venous thrombosis in 0.67%, two with pulmonary embolism (PE) and one with deep venous thrombosis (DVT). The TE were more common in critical than in non-critical patients (3.6% vs 0.3%). The number of CT pulmonary angiogram or duplex ultrasounds performed when PE/DVT was suspected was eighteen (4%), eight (47%) non-critically ill and ten (53%) in the ICU; the rate of radiographically positive results was 22.2%. The overall major bleeding rate was 2.5%, of these 91% were in the ICU. Mortality was 23.5% in the cohort. Table 1. No factors were found to be associated with thrombosis. The factors associated with bleeding were an INR &gt;1.2 (HR 9.0, 95% CI 1.2-67.3, p 0.03), IMPROVE score ≥7 (HR 81.3, 95% CI 11.9-555.6, p &lt; 0.01), and mechanical ventilation (HR 33.1, 95% CI 4.1-262.2, p 0.01). Factors associated with mortality were: age &gt;70 (HR 2.5, 95% CI 1.5-4.2, p &lt;0.01), D-Dimer &gt;3000 ng/mL (HR 2.0,95% CI 1.2-3.4, p &lt;0.01), and mechanical ventilation (HR 1.7, 95% CI 1.01-2.8, p = 0.02). The presence of more than 450x109/L platelets was associated with reduced mortality (HR 0.31 95% CI 0.19-0.50). Figure 1 Discussion: The late outbreak of COVID-19 in Latin America had led to an empiric use of aggressive thromboprophylaxis. Our data shows a low TE rate as compared with other groups, nevertheless we cannot prove a direct impact of the aggressive thromboprophylaxis, firstly because of the low rate or events, and secondly, due to the limitations of an observational study. On the other hand, the incidence of PE/DVT is conditioned by the number of studies performed, yet radiological confirmation has proven difficult due to concerns about virus exposure. Regarding the security of the intervention, major bleeding rates were slightly higher to what has been otherwise reported, but with no bleeding related deaths. The benefit of higher anticoagulant doses most be shown in clinical trials before we can recommend their generalized use in COVID-19 patients. Disclosures No relevant conflicts of interest to declare.

Abstract TP182: Risk of Acute Ischemic Stroke Increases During Severe Flares of Inflammatory Bowel Disease

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Benjamin R Kummer ◽  
Alexander E Merkler ◽  
Gino Gialdini ◽  
Hooman Kamel
Keyword(s):  
Inflammatory Bowel Disease ◽  
Ischemic Stroke ◽  
Bowel Disease ◽  
Sinus Thrombosis ◽  
Thrombotic Event ◽  
Venous Sinus ◽  
Index Hospitalization ◽  
Venous Sinus Thrombosis ◽  
Increased Risk ◽  
Inflammatory Bowel

Introduction: Flares of inflammatory bowel disease (IBD) have been associated with venous thromboembolism, and recent studies suggest an association between IBD and myocardial infarction. The association between IBD flares and cerebral thrombotic disease is less clear. We therefore sought to evaluate the risk of cerebral venous and arterial stroke during IBD flares. Hypothesis: IBD flares are associated with an increased risk of a cerebral thrombotic event. Methods: We used data on all admissions at nonfederal acute care hospitals in California, Florida, and New York to identify patients with a primary ICD-9-CM diagnosis code for ulcerative colitis or Crohn’s disease between 2005 and 2012. Patients with a documented abdominal surgery during the index hospitalization were excluded. An IBD flare was defined as a period of 120 days from the start of the index IBD-related hospitalization. Our outcomes were ischemic stroke and cerebral venous sinus thrombosis. We used a self-controlled case series design in which we compared the risk of a thrombotic event in the 120 days after hospitalization versus the risk during the 120 days prior to hospitalization. Results: We identified 31,993 patients with IBD, of whom 98 (0.31%) developed ischemic stroke. As compared with the control period preceding the index hospitalization, the risk of stroke was significantly elevated during the 120 days after IBD-related hospitalization (incidence rate ratio [IRR] 2.0; 95% confidence interval [CI] 1.3-3.0). In subgroup analyses, this elevated risk was apparent only in the 16,280 patients older than the median age of 44 years (IRR 1.9; 95% CI, 1.27-2.95), and not in the 15,713 patients younger than 44 years of age, among whom we identified only one stroke. We found only one patient with a documented venous sinus thrombosis and thus could not estimate the risk associated with an IBD flare. Conclusion: We found an association between IBD-related hospitalization and the risk of ischemic stroke in older patients. These results build on recent studies suggesting an association between IBD and the risk of arterial thrombotic events. Further research is needed to better define the association between IBD and cerebrovascular events, especially rare events such as cerebral sinus thrombosis.

d-Dimer Testing in Laboratory Practice

2011 ◽  
Vol 57 (9) ◽  
pp. 1256-1262 ◽  
Author(s):  
Armando Tripodi
Keyword(s):  
Thrombus Formation ◽  
Thrombotic Event ◽  
Secondary Prophylaxis ◽  
First Episode ◽  
Clinical Probability ◽  
Increased Risk ◽  
Recurrent Vte ◽  
High Concentrations ◽  
Laboratory Tool ◽  
D Dimer

BACKGROUND d-dimer is a reliable and sensitive index of fibrin deposition and stabilization. As such, its presence in plasma should be indicative of thrombus formation. There are many conditions unrelated to thrombosis in which d-dimer concentrations are high, however, making its positive predictive value rather poor. CONTENT Notwithstanding these limitations, d-dimer can be regarded as a most valuable laboratory tool to diagnose and manage a vast array of thrombosis-related clinical conditions, including (a) diagnosis of venous thromboembolism (VTE), (b) identification of individuals at increased risk of first thrombotic event (both arterial and venous), (c) identification of individuals at increased risk of recurrent VTE, (d) establishment of the optimal duration of secondary prophylaxis after a first episode of VTE, (e) pregnancy monitoring, and (f) diagnosis/monitoring of disseminated intravascular coagulation (DIC). This article is aimed at reviewing the merits and pitfalls of these applications. SUMMARY From my analysis of the literature, I draw the following conclusions. (a) d-dimer, as measured by a sensitive test, can be safely used to exclude VTE in symptomatic outpatients, provided that it is used in combination with the pretest clinical probability. (b) High concentrations of d-dimer are associated with an increased risk of recurrent VTE. (c) Patients who present with d-dimer above cutoff after stopping the regular course of oral anticoagulation benefit from extended prophylaxis. (d) Finally, d-dimer can be used as a fibrin-related degradation marker for the diagnosis/management of patients with DIC.

scholarly journals Clinical features, risk factors, and outcome of cerebral venous thrombosis in Tehran, Iran

2016 ◽  
Vol 7 (04) ◽  
pp. 554-558 ◽  
Author(s):  
Samira Yadegari ◽  
Askar Ghorbani ◽  
S Roohollah Miri ◽  
Mohammad Abdollahi ◽  
Mohsen Rostami
Keyword(s):  
Risk Factors ◽  
Magnetic Resonance ◽  
Clinical Features ◽  
Sinus Thrombosis ◽  
Oral Contraceptive Pill ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Underlying Disease ◽  
Tertiary Referral Hospital ◽  
D Dimer

ABSTRACT Introduction: Despite increasing the use of magnetic resonance imaging (MRI), cerebral venous sinus thrombosis (CVST) has remained an under-diagnosed condition. In this study, characteristics and frequency of various risk factors of CVST patients in a tertiary referral hospital were closely assessed. Methods: Patients with an unequivocal diagnosis of CVST confirmed by MRI and magnetic resonance venography during 6 years of the study were included. All data from the onset of symptoms regarding clinical signs and symptoms, hospital admission, seasonal distribution, medical and drug history, thrombophilic profile, D-dimer, neuroimaging, cerebrospinal fluid findings, mortality, and outcome were collected and closely analyzed. Result: A total of 53 patients with female to male ratio of 3.07 and mean age of 33.7 years were included in the study. Headache and papilledema were the most frequent clinical features (44 and 36 patients, respectively). An underlying disease (diagnosed previously or after admission) was the most common identified risk factor for CVST in both females and males (21 patients). A total of 15 women used the oral contraceptive pill (OCP) where 12 of them had simultaneously other predisposing factors. Overall, 19 patients (36%) had more than one contributing factor. D-dimer had a sensitivity of 71.4% in CVST patients. The mortality of patients in this study was 3.7% (n = 2). Focal neurologic deficit and multicranial nerve palsy were associated with poor outcome which defined as death, recurrence, and massive intracranial hemorrhage due to anticoagulation (P = 0.050 and 0.004, respectively). Conclusion: Unlike most of the CVST studies in which OCP was the main factor; in this study, an underlying disease was the most identified cause. Considering the high probability of multiple risk factors in CVST that was shown by this study, appropriate work up should be noted to uncover them.

Pulmonary thromboembolism

2017 ◽  
pp. 763-772
Author(s):  
Simone Wärntges ◽  
Katrin Schäfer ◽  
Stavros V. Konstantinides
Keyword(s):  
Older Adults ◽  
Oral Anticoagulants ◽  
Clinical Signs ◽  
Bleeding Risk ◽  
Clinical Probability ◽  
Age Related ◽  
Number Of Patients ◽  
Drug Pharmacokinetics ◽  
D Dimer ◽  
Predisposing Conditions

Venous thromboembolism (VTE) is the third most frequent acute cardiovascular syndrome; its annual incidence may reach 1200 cases per 100,000 population aged ≥80 years. Besides age-related increases in predisposing conditions, the ageing process itself shifts the balance between pro and anticoagulant pathways towards a propensity to thrombosis. Evaluation of symptoms and clinical signs of suspected VTE in older adults should take into account ‘physiologic’ age-related cardiopulmonary changes. Using age-adjusted (in patients older than 50 years) D-dimer cut-off levels in combination with low or intermediate clinical probability increases the number of patients in whom PE can reliably be excluded without imaging tests. Age is a key determinant of the bleeding risk under fibrinolytic and anticoagulation treatment. Overall, the new oral anticoagulants are effective and safe in older adults; however, age-related changes in renal and other organ function and drug pharmacokinetics mandate regular monitoring and possible dose adjustments.

Rationale, Design and Methods of the Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) Study

2021 ◽  
pp. 239698732110602
Author(s):  
Gerrit M. Grosse ◽  
Christian Weimar ◽  
Nils Kuklik ◽  
Anika Hüsing ◽  
Andreas Stang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Acute Stroke ◽  
Antithrombotic Therapy ◽  
Vitamin K Antagonists ◽  
Optimal Time ◽  
Optimal Timing ◽  
Real World Data ◽  
Index Event ◽  
Increased Risk ◽  
Design And Methods

Background The optimal timing of anticoagulation following acute ischaemic stroke or TIA in patients with atrial fibrillation (AF) is a frequent challenge. Early initiation of anticoagulation can reduce the risk for recurrent ischaemic events, but may lead to an increased risk for intracerebral haemorrhage. Aim The Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study was initiated to investigate outcome events under antithrombotic therapy after ischaemic stroke or TIA in patients with AF. The main objective is to compare the three-month rates of major haemorrhagic events between early (≤ 7 days) versus late (> 7 days) administration of dabigatran or treatment with vitamin-K antagonists started at any time. Occurrences of ischaemic and major haemorrhagic events will be evaluated to determine the optimal time point for initiation or resumption of anticoagulation. Design and Methods PRODAST is a prospective, multicenter, observational, non-interventional post-authorization safety study. 10,000 patients with recent (≤ 1 week from index event) ischaemic stroke or TIA and non-valvular AF were recruited at 86 German sites starting in July 2015. The observational plan includes a baseline visit, documentation of data during hospitalization and a telephone-based, central follow-up at three months after the index event. The primary endpoint is the major bleeding rate within three months. Secondary endpoints include rates of recurrent ischaemic or haemorrhagic stroke, TIA, systemic embolism, myocardial infarction and death. Summary PRODAST will provide important real-world data on safety and efficacy of antithrombotic therapy after acute stroke and TIA in patients with AF.

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