Evaluation of the Intra- and Post- Operative Bleeding After Simple Dental Extraction in Direct Oral Anticoagulant Therapy Patients: a Longitudinal Observational Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- post-operative bleeding complication
研究概览
简要总结
Direct Oral Anticoagulants were recently approved for medical treatment of several condition such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting sometimes the conventional oral anticoagulants. The aim of the present study is to observe the possible difference in intra-operative and post-operative bleeding events for single dental extraction.
详细描述
Many protocols of drug suspension for surgical procedure has been designed, since the introduction of anticoagulant or antiplatelet medications. Nowadays it is not certain if suspension could give more costs than benefits for the surgical procedure itself. With the recent development of the Direct Oral Anticoagulant it is still unclear whether these medications might bring more bleeding events in the intra-operative and post-operative phase after oral surgery procedure, equal to, or more than Oral Anticoagulant Therapy. The purpose of this study is to assess the degree of intra- and post-operative bleeding complication between direct oral anticoagulant therapy patients and Oral Anticoagulant Therapy patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients at 20 or more years of age.
- •Healthy patients (≤ American Society of Anesthesiologists 3).
- •Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Dabigatran (PRADAXA), Rivaroxaban (XARELTO), Apixaban (ELIQUIS), Edoxaban (LIXIANA).
- •Indication for extraction of a single tooth.
- •No other contraindications for tooth extraction.
- •Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
- •Signed informed consent.
排除标准
- •Smoke > 10 cigarettes per day.
- •Assumption of any antiplatelet medication.
- •Assumption of Heparin medication.
- •Assumption of oral anticoagulant medications (Warfarin, Coumadin).
- •Wash-out period after antiplatelet or Heparin medication at least 15 days.
- •Assumption of food or drugs that may alter direct oral anticoagulant blood values.
- •Uncontrolled Hypertension.
- •Uncontrolled Diabetes
- •Chronic Hepatitis and/or reduction of hepatic function
- •Coagulopathy (in excess of defect)
- •Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
- •Head and neck radiotherapy (previous 10 years).
- •Chemotherapy (previous 2 years).
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
- •Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
- •Pregnant or breastfeeding women.
- •Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
- •Oral Anticoagulant Therapy
- •Inclusion Criteria:
- •Male and female patients at 20 or more years of age.
- •General health status (< American society of anesthesiologist a 3).
- •Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM).
- •Indication for extraction of a single tooth.
- •No contraindications for tooth extraction.
- •Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
- •International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.
- •No diet changes within the week before blood sampling (avoiding interacting food)
- •Signed informed consent.
- •Exclusion Criteria:
- •Smoke > 10 cigarettes per day.
- •Assumption of any antiplatelet medication.
- •Assumption of any Heparin medication.
- •Assumption of any direct oral anticoagulant medication.
- •Uncontrolled Hypertension.
- •Uncontrolled Diabetes.
- •Chronic Hepatitis and/or reduction of hepatic function
- •Coagulopathy (in excess of defect)
- •Wash-out period after antiplatelet or Heparin medication at least 15 days.
- •Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
- •Assumption of food or drugs that may alter oral anticoagulant blood values.
- •Head and neck radiotherapy (previous 10 years).
- •Chemotherapy (previous 10 years).
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
- •Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
- •Pregnant or breastfeeding women.
- •Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
结局指标
主要结局
post-operative bleeding complication
时间窗: 30 minutes
questionnaire is provided to the patient for bleeding characterization
次要结局
- oral health status(1 week before)
- cardiological assessment(1 week before)
- intra-operative bleeding(intra-operative)
- bleeding risk assessment(1 week before)
研究者
prof. Roberto Di Lenarda
Prof.
University of Trieste