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[Diagnosis and treatment of coagulation disorders].

INTRODUCTION: Approximately 5% of all cerebrovascular events (CVE), and 10% of those occurring in young patients, are due to hematological disorders. Hypercoagulability states are related to CVE in young patients, deep vein thrombosis, recurrent thromboses, pulmonary embolism, a family history of thrombosis and unusual venous and arterial thromboses. DEVELOPMENT: The conditions related to increased risk of thrombosis are: the congenital thrombophilias due to deficiency of protein C, protein S or antithrombin III, resistance to protein C activated by Leiden's factor V--cofactor of protein C with genetic mutation--; the primary antiphospholipid syndrome with anticardiolipin antibodies and lupus inhibitor; platelet disorders, deficit of heparin cofactor II, deficit of plasminogen and plasminogen tissue activator (t-PA) and increase in the inhibitor of plasminogen tissue activator (PAI-I); alterations in factors of coagulation such as deficits of factor VII and factor XIII, mutation of prothrombin 20210-->A, increase in factor VIII. Hyperfibrinogenemia and hyperhomocysteinemia are also independent risk factors for CVE. CONCLUSION: The patients, especially young patients, with recurrent thrombosis or thrombosis of unknown origin should be assessed seeking clinical and serological signs of the primary antiphospholipid syndrome or other coagulopathies. Although we still have no results of controlled prospective studies regarding these conditions, long term anticoagulation is recommended on the findings of small-scale retrospective studies.

Anticoagulants↗
PubMed1999

[Information provided in writing for "informed consent" in clinical trials].

The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration. 61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated. The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment. Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

Clinical Trials as Topic↗
PubMed2000

Paying for clinical trials.

Explore the source record for details and available documents.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2001

Recruitment and retention of elderly patients in clinical trials: issues and strategies.

Clinicians and researchers alike are shifting their focus to elderly patients in order to target the most effective treatments for a variety of psychiatric conditions. Clinical trials with elderly patients are the necessary because they consume the largest number of prescription medications. There are special challenges and considerations in designing and conducting clinical studies. The authors review the various phases of such research, including recruitment of appropriate patients and retention of those enrolled, and they make suggestions, using examples from already completed research studies, illustrating the methods found to be most successful.

Aged↗