Haemostasis and Thrombosis Center

Cremona, Italy

Haemostasis and Thrombosis Center

Cremona, Italy
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Rangarajan S.,Haemostasis and Thrombosis Center | Rangarajan S.,King's College London
Haemophilia | Year: 2011

Von Willebrand factor (VWF) has multiple functions in coagulation. It is a clotting protein and its deficiency causes a primary haemostatic bleeding disorder. Excess VWF, particularly high molecular weight multimers can cause thrombosis. There is also a debatable function of protecting factor VIII (FVIII) in circulation with the prevention of development of FVIII inhibitors. This commentary addresses these functions. © 2010 Blackwell Publishing Ltd.

Poli D.,AOU Careggi | Antonucci E.,AOU Careggi | Testa S.,Haemostasis and Thrombosis Center | Tosetto A.,S Bortolo Hospital | And 2 more authors.
Circulation | Year: 2011

Background-: Vitamin K antagonist (VKA) therapy is increasingly being used for the prevention of venous thromboembolism and stroke in atrial fibrillation. Bleeds are the major concern for VKA prescription, especially in very old patients who carry many risk factors for bleeding. We performed a large multicenter prospective observational study that enrolled very old patients to evaluate the quality of anticoagulation and the incidence of bleedings. Methods and results-: The study included 4093 patients 80 years of age who were naïve to VKA for thromboprophylaxis of atrial fibrillation or after venous thromboembolism. Patients demographic and clinical data were collected, and the quality of anticoagulation and the incidence of bleeding were recorded. The follow-up was 9603 patient-years; median age at the beginning of follow-up was 84 years (range, 80 to 102 years). We recorded 179 major bleedings (rate, 1.87 per 100 patient-years), 26 fatal (rate, 0.27 per 100 patient-years). The rate of bleeding was higher in men compared with women (relative risk, 1.4; 95% confidence interval, 1.12 to 1.72; P=0.002) and among patients 85 years of age compared with younger patients (relative risk, 1.3; 95% confidence interval, 1.0 to 1.65; P=0.048). Time in therapeutic range was 62% (interquartile range, 49% to 75%). History of bleeding, active cancer, and history of falls were independently associated with bleeding risk in Cox regression analysis. Conclusion-: In this large study on very old patients on VKA carefully monitored by anticoagulation clinics, the rate of bleedings was low, suggesting that age in itself should not be considered a contraindication to treatment. Adequate management of VKA therapy in specifically trained center allows very old and frail patients to benefit from VKA thromboprophylaxis. © 2011 American Heart Association. All rights reserved.

Rangarajan S.,St Thomas Hospital | Rangarajan S.,Haemostasis and Thrombosis Center | Austin S.,St Georges Hospital | Goddard N.J.,Royal Free Hospital | And 5 more authors.
Haemophilia | Year: 2013

Summary: A growing number of publications have described the efficacy and safety of FEIBA as a first-line haemostatic agent for surgical procedures in haemophilia A patients with high-responding FVIII inhibitors. The aim of this study was to provide practical guidance on patient management and selection and also to communicate a standardized approach to the dosing and monitoring of FEIBA during and after surgery. A consensus group was convened with the aims of (i) providing an overview of the efficacy and safety of FEIBA in surgery; (ii) sharing best practice; (iii) developing recommendations based on the outcome of (i) and (ii). To date there have been 17 publications reporting on the use of FEIBA in over 210 major and minor orthopaedic and non-orthopaedic surgical procedures. Haemostatic outcome was rated as 'excellent' or 'good' in 78-100% of major cases. The reporting of thromboembolic complications or anamnestic response to FEIBA was very rare. Key to the success of FEIBA as haemostatic cover in surgery is to utilize the preplanning phase to prepare the patient both for surgery and also for rehabilitation. Haemostatic control with FEIBA should be continued for an adequate period postoperatively to support wound healing and to cover what can in some patients be an extended period of physiotherapy. Published data have demonstrated that FEIBA can provide adequate, well tolerated, peri and postoperative haemostatic cover for a variety of major and minor surgical procedures in patients with haemophilia A. The consensus recommendations provide a standardized approach to the dosing and monitoring of FEIBA. © 2012 Blackwell Publishing Ltd.

Poli D.,Thrombosis Center | Antonucci E.,University of Florence | Testa S.,Haemostasis and Thrombosis Center | Ageno W.,University of Insubria | Palareti G.,S. Orsola Malpighi University Hospital
Thrombosis Research | Year: 2013

Introduction: The prevalence of AF is higher in men and increases with age. However, the number of elderly women is higher than that of elderly men, and AF should be considered to affect men and women equally. Little information exists on elderly AF patients, and in particular, whether stroke and bleeding risk differs between elderly women and elderly men remains unknown. Methods: We have performed the EPICA Study, a large, multicentre observational study including 4093 elderly patients who started VKA treatment after the age of 80 years. In this study, we will focus our analysis on 3015 AF patients followed for 7620 patient-years (pt-yrs) to evaluate if bleeding and stroke risks were different between genders. Results: During follow-up, we recorded 112 ischemic cerebral events (rate 1.5 × 100 pt-years) with no difference between genders. History of previous stroke/TIA, hypertension and artery vascular disease are independently associated with stroke/TIA during treatment. We recorded 132 major bleeds (rate 1.7 × 100 pt-years); males showed a higher risk of bleeding (OR 1.5), even if not statistically significant. At multivariate analysis, history of major bleeds, history of falls and active cancer are risk factors independently associated to bleeding. Conclusion: Elderly patients with AF do not show clear gender related differences in the risk of major adverse events. However, elderly males showed a higher rate of bleeding complications, and females showed a slightly higher rate of stroke, thus suggesting the possibility of a higher net clinical benefit of anticoagulant treatment in females. © 2012 Elsevier Ltd. All rights reserved.

Poli D.,Thrombosis Center | Testa S.,Haemostasis and Thrombosis Center | Antonucci E.,University of Florence | Grifoni E.,University of Florence | And 2 more authors.
Chest | Year: 2011

Background: All stroke risk stratification schemes categorize a history of stroke as a "truly high" risk factor. Therefore, stratifying stroke risk in atrial fibrillation (AF) should perhaps concentrate on primary prevention. However, the risk factors for stroke also lead to an increase in the risk of bleeding. Our objective was to evaluate the agreement among the currently used stroke risk stratification schemes in "real-world" patients with AF in the primary prevention setting, their correlation with adverse events recorded during warfarin treatment, and the relationship between stroke and bleeding risk. Methods: We prospectively followed up 3,302 patients with AF taking warfarin for primary prevention. Stroke risk was assessed using the CHADS 2 (congestive heart failure, hypertension, age ≥ 75 years, diabetes, previous stroke or transient ischemic attack), Atrial Fibrillation Investigators, American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy, American College of Cardiology/American Heart Association/European Society of Cardiology, and National Institute for Health and Clinical Excellence schemas, and for bleeding risk, the outpatient bleeding risk index was calculated. Bleeding and thrombotic events occurring during follow-up were recorded. Results: Patients classified into various stroke risk categories differed widely for different schemes, especially for the moderate- and high-risk categories. The rates of bleeding and thrombotic events during follow-up were 1.24 and 0.76 per 100 patient-years, respectively. All stroke stratification schemes correlated closely to bleeding risk. Stroke rate increased progressively from lowto moderate- to high-risk patients. Conclusions: Stroke risk stratification models differed widely when categorizing subjects into the moderate- and high-stroke-risk categories. Bleeding and stroke risk were closely correlated and both were low among low-risk patients and were similarly high among moderate/high-risk groups.© 2011 American College of Chest Physicians.

Poli D.,Thrombosis Center | Antonucci E.,University of Florence | Testa S.,Haemostasis and Thrombosis Center | Lip G.Y.H.,University of Birmingham
Internal and Emergency Medicine | Year: 2014

Stroke prevention, achieved with oral anticoagulation therapy (OAT), is central to the management of patients with atrial fibrillation (AF). Well-managed OAT, as reflected by a long time in therapeutic range (TTR), is associated with good clinical outcomes. The SAME-TT2R2 score has been proposed to identify patients who will maintain a high average TTR on vitamin K antagonists (VKA) treatment. The objective of the study was to validate this score in a cohort of AF patients followed by an anticoagulation clinic. We applied the SAME-TT2R2 score to 1,089 patients with AF on VKAs followed by two anticoagulation clinics. The median TTR overall for the whole cohort was 73.0 %. There was a significant decline in mean (or median) TTR in relation to the SAME-TT2R2 score (p = 0.042). When the SAME-TT2R2 scores were categorized we find a TTR 74.0 % for score ≤2 and 68.0 % for score >2 (p = 0.006). The rate of major bleeding events and stroke/TIA was 1.78 × 100 patient-years (pt-yrs) and 1.26 × 100 pt-yrs, respectively. No relationship exists between the SAME-TT2R2 score and adverse events. We describe the first validation of the SAME-TT2R2 score in AF patients where, despite an overall good quality of anticoagulation, the SAME-TT2R2 score is able to identify the patients who are less likely to do well on VKA therapy if this is the chosen OAT. © 2014 SIMI.

Rangarajan S.,St Thomas Hospital | Rangarajan S.,Haemostasis and Thrombosis Center | Yee T.T.,Royal Free Hospital NHS Trust | Wilde J.,University of Birmingham
Haemophilia | Year: 2011

Increasing evidence indicates that factor VIII (FVIII) inhibitor bypassing agents (FEIBA® and NovoSeven®) can provide effective peri-operative haemostasis in haemophilia patients with high-responding inhibitors. We report the collected experience of all major and minor surgeries, conducted between December 1998 and September 2008, at four UK haemophilia Comprehensive Care Centres with FEIBA® as the first-line bypassing agent in patients with inhibitors. A total of 26 surgical procedures were performed in 18 patients of ages 34-83years including five patients with acquired FVIII inhibitors. A single pre-operative infusion of FEIBA was followed by 6-12h interval dosing for major surgeries at the discretion of the physician to approximate a maximum of 200Ukg-1day-1, with tapering when postoperative haemostasis and wound healing permitted. Haemostatic outcomes were retrospectively reviewed against European consensus thresholds for blood loss and duration of treatment compared with expectations for equivalent procedures in non-inhibitor patients. Peri-operative haemostatic outcome with FEIBA was rated excellent or good in 78% of 18 major surgeries in 12 patients, including 11 major orthopaedic procedures. Haemostatic outcome was rated excellent in all seven procedures in five patients with acquired FVIII inhibitors and in all eight minor surgical procedures in six patients. FEIBA was well tolerated with no intra-operative haemostatic complications. A single, transient postoperative thrombotic adverse event occurred in a patient with cerebrovascular disease. This case series adds significantly to existing evidence that FEIBA can provide adequate, well-tolerated, peri-operative haemostatic cover for a wide variety of major and minor surgical procedures. © 2010 Blackwell Publishing Ltd.

Testa S.,Haemostasis and Thrombosis Center | Paoletti O.,Haemostasis and Thrombosis Center | Bassi L.,Haemostasis and Thrombosis Center | Dellanoce C.,Haemostasis and Thrombosis Center | And 2 more authors.
International Journal of Laboratory Hematology | Year: 2015

Introduction: Although most guidelines for quality assessment of INR PMs recommend specific procedures, no clear regulation or methodology is required for outpatients in our country. We have developed a specific INR portable monitor (PM) quality control system within our telemedicine organization to check over time quality performances and plan corrective actions. Methods: Based on current guidelines for laboratory QC, the following aspects were assessed: suitability of PM, defined in terms of imprecision and accuracy; intra-assay imprecision, defined according to monthly revision of Levey-Jennings cards with data from each peripheral healthcare unit (PHU), using an internal QC provided by the manufacturer (CV ± 20% considered as acceptable); quarterly accuracy study, for assessing agreement between analytical instruments, based on duplicate analysis of three samples with INR values reflecting different therapeutic ranges (differences ± 0.5 considered as acceptable); external quality assessment (NEQAS). Results: In the nine PHU, 18 portable monitors were used to perform 22 929 test during year 2010. Analytical imprecision was low, showing CVs always <5%. Accuracy check showed two of 216 results out of range (0.92%), thus providing timely indication for instrument replacement. The external QC NEQAS showed optimal performance. Conclusion: The current protocol for INR PMs quality assessment was effective to establish and maintain a reliable control of devices, ensuring the quality of analytical data over time. National authorities should be prompted to guarantee and apply correct protocols for INR-PM use. © 2014 John Wiley & Sons Ltd.

Bosch M.M.,German Trias y Pujol Hospital | Vignoli A.,Haemostasis and Thrombosis Center | Villamediana R.L.,University of Navarra | Prandoni P.,University of Padua
Drugs | Year: 2010

An association between cancer and thrombosis has been recognized since 1865. It is considered to be a two-way association; cancer is associated with an increased risk of venous thromboembolism (VTE), whereas activation of the coagulation cascade enhances the proliferation, angiogenesis potential andmetastasis of tumour cells. A sizeable proportion of VTE events in cancer patients undergoing major surgery occur after discharge from hospital, suggesting that extended thromboprophylaxis beyond the normal 7-10 days is warranted in these patients. Studies have demonstrated reduced incidences of VTE with extended thromboprophylaxis using low molecular weight heparins (LMWH) and guidelines recommend continuing thromboprophylaxis after discharge in patients who have undergonemajor cancer surgery, but the evidence is still considered limited and of low quality, and the recommendations have not been widely implemented in clinical practice. Extended prophylaxis with bemiparin was shown to reduce significantly the incidence of major VTE in patients undergoingmajor cancer surgery in the Cancer, Bemiparin and Surgery Evaluation study, providing further support for the routine use of extended thromboprophylaxis with LMWH in cancer patients. Heparins, particularly LMWH, in addition to preventing VTE in cancer patients, can block tumour cell growth, invasion, metastasis and angiogenesis. As with other LMWH, bemiparin and its ultra-low molecular weight derivative, RO-14, appear to be effective in preventing angiogenesis in in-vitro models. Recent clinical studies have demonstrated significant survival advantages when LMWH have been added to chemotherapy in cancer patients. This could be partly due, not only to the prevention of thromboembolic diseases in these patients, but also to 'direct' antineoplastic properties of LMWH. The survival benefits appeared greater in patients with limited cancer, especially limited small cell lung cancer. The Adjuvant Bemiparin in Small Cell Lung Cancer study is assessing the effect of bemiparin on survival in patients with limited small cell lung cancer, and although results are not yet available, preliminary data appear very promising. © 2010 Adis Data Information BV.

Santoro R.,Haemostasis and Thrombosis Center | Prejano S.,Haemostasis and Thrombosis Center | Iannaccaro P.,Haemostasis and Thrombosis Center
Blood Coagulation and Fibrinolysis | Year: 2011

Factor XI (FXI) deficiency is a rare bleeding disorder, resulting in a wide range of bleeding manifestations, from asymptomatic bleeding to injury-related bleeding. First in this review, we give an overview of the basic pathophysiology, clinical manifestations, and management of FXI deficiency. Finally, we describe 34 members of 16 FXI-deficient kindreds from south Italy, diagnosed and followed at the Haemophilia, Haemostasis and Thrombosis Centre of Pugliese-Ciaccio Hospital, Catanzaro, during the past 20 years. In our patients, bleeding tendency did not appear to be correlated with FXI levels. Furthermore, we describe 24 pregnancies in 11 patients with FXI deficiency. In all the pregnancies, no bleeding manifestations were reported. © 2011 Wolters Kluwer Health. Lippincott Williams & Wilkins.

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