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Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study

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PATIENT SAFETY IN SURGERY 2009年第1期3卷 13-13页

作者： Birth, Mathias Figueras, Joan Bernardini, Stephane Troen, Tine Guenther, Klaus Mirza, Darius Mortensen, Frank Viborg HANSE Klin Stralsund Klin Allgemein Viszeral Thorax & Gefasschirurg Stralsund Germany Dr Josep Trueta Hosp IDiBGi Serv Cirug Gen Girona Spain CHU St Jacques Serv Urol Besancon France Biostat Nycomed Roskilde Denmark Klin Hallerwiese Abt Allgemein & Viszeralchirurg Nurnberg Germany Queen Elizabeth Hosp Birmingham Childrens Hosp Liver Unit Birmingham W Midlands England Aarhus Univ Hosp Kirurg Gastroenterol Afdel NBG Aarhus Denmark

Background: Topical haemostatic agents are used to help achieve haemostasis during surgery when standard surgical techniques are insufficient. The objective of this study was to confirm the safety profile of an equine collagen patch coated with human fibrinogen and human thrombin with particular focus on the occurrence of thromboembolic events (TEEs), major bleeding and immunological events. Methods: This was a non-interventional, multicentre, prospective, surveillance study in which a collagen fleece-bound fibrin sealant was prescribed in accordance with its marketing authorisation. The decision to use the sealant was based solely on current surgical practice. All patients that received the sealant and provided informed consent were included. TEEs (any coagula-based occlusion in a vessel or the heart identified by symptomatic clinical signs and/or verified by paraclinical examination), major bleeding (any bleeding that required intervention), and immunological events (hypersensitivity including anaphylaxis) that occurred during surgery, post-operative hospital stay or 6 months of follow-up were reported as adverse events. The primary endpoint was the proportion of patients experiencing a confirmed TEE. Results: A total of 3098 patients were recruited at 227 centres in 12 European countries. The most frequent types of surgery were hepatic (33%), gastrointestinal (16%) and urological (14%) and the main indication for surgery was for primary (35%) or secondary (20%) malignancy. Forty-six patients (1.5%, 95% CI 1.1-2.0%) had at least one TEE during the study. The most commonly reported TEEs were pulmonary embolism or post-procedural pulmonary embolism (n = 18) and deep vein thrombosis (n = 9). There were 64 major bleedings in 62 patients and 9 immunological events in 8 patients. Conclusion: Collagen fleece-bound fibrin sealant does not appear to be associated with an increased risk of TEEs, major bleeding or immunological events in patients undergoing surgery.

关键词： Major Bleeding Portal Vein Thrombosis Fibrin Sealant Immunological Event data monitoring committee

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Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial

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TRIALS 2008年第2008期9卷 1-13页

作者： Meyhoff, Christian S. Wetterslev, Jorn Jorgensen, Lars N. Henneberg, Steen W. Simonsen, Inger Pulawska, Therese Walker, Line R. Skovgaard, Nina Helto, Kim Gocht-Jensen, Peter Carlsson, Palle S. Rask, Henrik Karim, Sharaf Carlsen, Charlotte G. Jensen, Frank S. Rasmussen, Lars S. Univ Copenhagen Hosp Rigshosp Ctr Head & Orthopaed Dept Anaesthesia DK-2100 Copenhagen Denmark Univ Copenhagen Hosp Rigshosp Ctr Clin Intervent Res Copenhagen Trial Unit DK-2100 Copenhagen Denmark Univ Copenhagen Bispebjerg Hosp Dept Surg Copenhagen Denmark Univ Copenhagen Hosp Rigshosp Juliane Marie Ctr Dept Anaesthesia DK-2100 Copenhagen Denmark Vejle Hosp Dept Surg Vejle Denmark Copenhagen Univ Hosp Dept Surg Herlev Denmark Nykobing Falster Hosp Dept Anesthesia Nykobing Denmark Slagelse Hosp Dept Surg Slagelse Denmark Aarhus Univ Hosp Dept Anesthesiol DK-8000 Aarhus Denmark Odense Univ Hosp Dept Anaesthesiol Svendborg Denmark Naestved Hosp Dept Surg Naestved Denmark Viborg Hosp Dept Surg Viborg Denmark Copenhagen Univ Hosp Dept Anaesthesia Gentofte Denmark

Background: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receiving FiO2 = 0.80. It has not been settled if a high inspiratory oxygen fraction increases the risk of pulmonary complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery. Methods and design: The PROXI-Trial is a randomized, patient- and assessor blinded trial of perioperative supplemental oxygen in 1400 patients undergoing acute or elective laparotomy in 14 Danish hospitals. Patients are randomized to receive either 80% oxygen (FiO(2) = 0.80) or 30% oxygen (FiO(2) = 0.30) during surgery and for the first 2 postoperative hours. The primary outcome is surgical site infection within 14 days. The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit. The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power. Discussion: This trial assesses benefits and harms of a high inspiratory oxygen fraction, and the trial may be generalizable to a general surgical population undergoing laparotomy. Trial registration: *** identifier: NCT00364741.

关键词： Supplemental Oxygen Relative Risk Reduction data monitoring committee Post Anaesthesia Care Unit Oxygen Fraction

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monitoring clinical trial data using an unblinded industry statistician

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DRUG INFORMATION JOURNAL 2008年第2期42卷 193-199页

作者： Baggs, Geraldine E. Seth, Anand Oliver, Jeffery S. Jones, Wendy M. Liu, Linna Toth, Susan M. Abbott Labs Abbott Nutr Res & Dev Columbus OH 43215 USA

The three-statistician model of monitoring data from an ongoing trial generated strong reactions from the statistical community. At controversy is the recommendation that an independent statistician serves as unblinded liaison to the data monitoring committee (DMC). We share our experience with using an industry statistician as the unblinded liason in a study on the early treatment of patent ductus arteriosus in premature infants. The DMC memebership included an academic consulting statistician. A DMC charter was drawn up laying down the expectation for committee members. The study statistician were not involved in dealings with the DMC. Only the liaison statistician responsible for generating reports and analyses was aware of the grouped results A versus B. A report generation process was established ensuring a firewall for maintaining confidentiality of results. In certain situations, employing an industry statistician as the unblinded liaison to the DMC is a viable option for monitoring data.

关键词： data monitoring committee unblinded industry statistician FDA guidance

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MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes

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BMC Pregnancy and Childbirth 2008年第1期8卷 1-9页

作者： Kenyon, Sara Brocklehurst, Peter Jones, David Marlow, Neil Salt, Alison Taylor, David Reproductive Sciences Section University of Leicester Leicester LE2 7LX United Kingdom NPEU Institute of Health Sciences Headington Oxford OX3 7LF Old Road United Kingdom Department of Health Sciences University of Leicester Leicester LE2 7LX United Kingdom Child Health Queens Medical Centre Nottingham NG7 2UH United Kingdom Great Ormond Street Hospital for Sick Children London WC1N 3JH Great Ormond Street United Kingdom

Background: The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate. Methods: The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents. National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England. Discussion: This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age. © 2008 Kenyon et al;licensee BioMed Central Ltd.

关键词： Cerebral Palsy Chronic Lung Disease data monitoring committee Trial Steering committee Local Education Authority

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Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

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BMC MEDICAL RESEARCH METHODOLOGY 2008年第1期8卷 51-51页

作者： Hovi, Sirpa-Liisa Veerus, Piret Rahu, Mati Hemminki, Elina Natl Res & Dev Ctr Welf & Hlth STAKES Finnish Off Hlth Technol Assessment Finohta FI-00531 Helsinki Finland Natl Inst Hlth Dev TAI Dept Epidemiol & Biostat EE-11619 Tallinn Estonia Univ Tartu Estonian Ctr Excellence Behav & Hlth Sci Dept Psychol EE-50410 Tartu Estonia Natl Res & Dev Ctr Welf & Hlth STAKES Hlth & Social Serv FI-00531 Helsinki Finland

Background: Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods: The Estonian Postmenopausal Hormone Therapy trial (EPHT), originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM) in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT) on health services utilization. Results: After EPHT recruited in 1999-2001 the Women's Health Initiative (WHI) in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion: Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an ( old) drug for a new preventive indication? In preventive drug trials companies may donate drugs but they take

关键词： Hormone Therapy Conjugate Equine Estrogen data monitoring committee Health Insurance Fund Trial Steering committee

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Investigation of the effect of Interleukin-1 receptor antagonist (IL-Ira) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)

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TRIALS 2008年第2008期9卷 8-8页

作者： Crossman, David C. Morton, Allison C. Gunn, Julian P. Greenwood, John P. Hall, Alistair S. Fox, Keith Aa Lucking, Andrew J. Flather, Marcus D. Lees, Belinda Foley, Claire E. Univ Sheffield Sch Med & Biomed Sci Cardiovasc Res Unit Sheffield S10 2RX S Yorkshire England Leeds Gen Infirm Acad Unit Cardiovasc Med Leeds LS1 3EX W Yorkshire England Univ Edinburgh Queens Med Res Inst Ctr Cardiovasc Sci Edinburgh EH16 4TJ Midlothian Scotland Royal Brompton & Harefield NHS Trust Clin Trials Evalut Unit London SW3 6NP England

Background: Acute Coronary Syndromes account for 15% of deaths in the UK, and patients remain at significant risk of re-admission for future complications and death. Pathologically the underlying process of atherosclerosis is driven by inflammatory mechanisms, which are activated in ACS patients. Previous studies have investigated the role of inflammatory markers in this process, including interleukin 1 (IL-1) and C Reactive Protein (CRP). Pre-clinical studies indicate that IL-1 may be a primary driver of ACS and that the naturally occurring interleukin-I receptor antagonist (IL-Ira) may inhibit the atherosclerotic process. This study will investigate the effects of IL-Ira on inflammatory markers in man. Methods/design: Three centres in the UK are planning to recruit 186 Non-ST elevation myocardial infarction patients to receive either interleukin-I receptor antagonist (Anakinra) or matching placebo. Patients will receive a daily subcutaneous injection of either study drug or placebo over a 14 day period. The primary outcome is area under the curve of high sensitivity C-Reactive Protein (CRP) over the first 7 days. Discussion: The MRC-ILA-HEART Study is a proof of concept clinical trial investigating the effects of IL-Ira upon markers of inflammation in patients with Non-ST elevation myocardial infarction. It is hoped this will provide new and exciting information in relation to an "anti-inflammatory" strategy for patients with acute coronary syndrome. Trial registration: ISRCTN89369318.

关键词： Acute Coronary Syndrome Cardiac Magnetic Resonance Acute Coronary Syndrome Patient data monitoring committee Trial Steering committee

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Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial

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TRIALS 2008年第2008期9卷 6-6页

作者： Rajendram, Rathie Lee, Richard W. J. Potts, Mike J. Rose, Geoff E. Jain, Rajni Olver, Jane M. Bremner, Fion Hurel, Steven Cook, Anne Gattamaneni, Rao Tomlinson, Marjorie Plowman, Nicholas Bunce, Catey Hollinghurst, Sandra P. Kingston, Laura Jackson, Sue Dick, Andrew D. Rumsey, Nichola Morris, Olivia C. Dayan, Colin M. Uddin, Jimmy M. Univ Bristol Dept Clin Sci S Bristol Bristol Avon England Moorfields Eye Hosp London EC1V 2PD England Bristol Eye Hosp Bristol BS1 2LX Avon England Western Eye Hosp London NW1 5YE England Natl Hosp Neurol & Neurosurg Dept Neuroophthalmol London WC1N 3BG England UCL Hosp London NW1 2PQ England Manchester Royal Eye Hosp Manchester M13 9WH Lancs England Christie Hosp NHS Trust Manchester M20 4BX Lancs England Bristol Haematol & Oncol Ctr Bristol BS2 8ED Avon England St Bartholomews Hosp London EC1A 7BE England Univ Bristol Dept Community Based Med Acad Unit Primary Hlth Care Bristol BS8 2AA Avon England Univ W England Ctr Appearance Res Bristol BS16 2JP Avon England Univ Bristol Henry Welcome Labs Integrat Neurosci & Endocrinol Bristol BS1 3NY Avon England

Background: Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed. The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. Methods/design: Patients with active thyroid eye disease will be randomised to receive (i)azathioprine or oral placebo and (ii) radiotherapy or sham- radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures. Discussion: The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug;(b) constructing effective inclusion and exclusion criteria to select for active disease;and (c) selecting pragmatic outcome measures.

关键词： data monitoring committee Trial Steering committee Electronic Portal Image Device Trial Subject Clinical Activity Score

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Cambridge Breast Intensity Modulated Radiotherapy Trial: dosimetry results for 1,139 patients

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BREAST CANCER RESEARCH 2008年第s2期10卷 S38-S38页

作者： Coles, C. E. Wilkinson, J. S. Wilson, C. B. Burnet, N. G. Wishart, G. C. Twyman, N. Hoole, A. C. F. Moody, A. M. Univ Cambridge Hosp NHS Fdn Trust Cambridge England

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Release of data from an ongoing randomized clinical trial for sample size adjustment or planning

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STATISTICS IN MEDICINE 2007年第22期26卷 4074-4082页

作者： Freidlin, Boris Korn, Edward L. NCI Biometr Res Branch Div Canc Traetment & Diagnosis Bethesda MD 20892 USA

The determination of an appropriate sample size is a key issue in planning and designing randomized clinical trials. In settings with time-to-event or binary outcomes, the required sample size depends on the control-arm event (response) rate. An accurate estimate of this rate is not often available at the planning stage. Therefore, non-comparative control-arm or pooled-arm event rates from an ongoing trial are sometimes released for sample size adjustment or planning purposes. It is shown that such noncomparative data release may still contain information on the relative treatment benefit and may thus adversely affect the ongoing trial. A simple approach to minimizing the effect of the data release is suggested. Published in 2007 by John Wiley & Sons, Ltd.

关键词： bayesian analysis interim analysis administrative analysis data monitoring committee data release

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Community health and medical provision: Impact on neonates (the CHAMPION trial)

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BMC Pediatrics 2007年第1期7卷 1-11页

作者： Boone, Peter Mann, Vera Eble, Alexander Mendiratta, Tarana Mukherjee, Rohini Figueiredo, Ryan Jayanty, Chitra Frost, Chris Padmanabh, M. Reddy Elbourne, Diana Department of Effective Intervention Centre for Economic Performance London School of Economics London Houghton Street United Kingdom Medical Statistics Unit London School of Hygiene and Tropical Medicine London Keppel Street United Kingdom Global Partnerships Naandi Foundation Hyderabad - 500034 Road 2 Banjara Hills India NICE Foundation Abids Hyderabad - 500001 4-1-1056 Bogulkunta India

Background: The trial aims to evaluate whether neonatal mortality can be reduced through systemic changes to the provision and promotion of healthcare. Neonatal mortality rates in India are high compared to other low income countries, and there is a wide variation of rates across regions. There is evidence that relatively inexpensive interventions may be able to prevent up to 75% of these deaths. One area with a particularly high rate is Mahabubnagar District in Andhra Pradesh, where neonatal mortality is estimated to be in the region of 4-9%. The area suffers from a vicious cycle of both poor supply of and small demand for health care services. The trial will assess whether a package of interventions to facilitate systemic changes to the provision and promotion of healthcare may be able to substantially reduce neonatal mortality in this area and be cost-effective. If successful, the trial is designed so that it should be possible to substantially scale up the project in regions with similarly high neonatal mortality throughout Andhra Pradesh and elsewhere. Methods/Design: This trial will be a cluster-randomised controlled trial involving 464 villages in Mahabubnagar District. The package of interventions will first be introduced in half of the villages with the others serving as controls. The trial will run for a period of three years. The intervention in the trial has two key elements: a community health promotion campaign and a system to contract out healthcare to non-public institutions. The health promotion campaign will include a health education campaign, participatory discussion groups, training of village health workers and midwives, and improved coordination of antenatal services. The intervention group will also have subsidised access to pregnancy-related healthcare services at non-public lth centres (NPHCs). The primary outcome of the trial will be neonatal mortality. Secondary outcomes will include age at and cause of neonatal death, neonatal morbidity,

关键词： Neonatal Mortality Eligible Woman Health Knowledge data monitoring committee Trial Steering committee

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