ISRCTN69942081已完成4 期
Prospective clinical trial, phase IV, controlled randomized, double-blind, parallel-group for evaluate the safety and efficacy of Tetanus vaccination in patients taking oral anticoagulants. Comparing the subcutaneous versus intramuscular injection of Tetanus vaccination.
Department of Health of Galicia (Spain)0 个研究点目标入组 234 人开始时间: 2012年2月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
研究概览
简要总结
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25168768 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36619617/ (added 09/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. All patients, whose control were being performed at 15 Health Centres (Vigo Primary Care Area)
- •2. Patients treated with oral anticoagulants, where administering at least one dose of anti-tetanus vaccine was indicated. This was for those whose vaccination status was unknown, uncertain or if they were clearly not vaccinated.
- •3. Patients giving written consent to be vaccinated and participate in the study after being duly informed.
排除标准
- •1. Severe local reaction to previous doses with affection of the whole circumference of the injected limb
- •2. Peripheral neurological disorders due to previous doses
- •3. Severe anaphylactic reaction due to previous doses or any of the components
- •4. Bad haematologic control (INR>4) in the last 2 months
- •5. Serious illness, terminal stages of diseases, immobilized, adversely affected chronic pathology or immunosuppressive states
- •6. Pregnant or breast-feeding women
研究者
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