Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- bleeding complication
研究概览
简要总结
Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs.
To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs.
To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.
Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group.
Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.
Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.
详细描述
The continuous variables (amount of bleeding during surgery) will be analyzed with linear regression if they show normal distribution patterns.
The ordinal variables (postoperative bleeding complications) will be analyzed with ordinal logistic regression.
Dichotomous variables (presence of other postoperative complications) will be analyzed with logistic regression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need of dental extraction / oral surgery, and medication with:
- •warfarin or
- •no treatment or AK-platelet therapy and age-matched to group a) and b).
排除标准
- •Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
研究组 & 干预措施
DOAC
Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
干预措施: Type of surgery (Procedure)
DOAC
Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
干预措施: Dabigatran (Drug)
DOAC
Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
干预措施: Rivaroxaban (Drug)
DOAC
Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
干预措施: Apixaban (Drug)
DOAC
Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
干预措施: Edoxaban (Drug)
Warfarin
A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.
干预措施: Type of surgery (Procedure)
Warfarin
A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.
干预措施: Warfarin (Drug)
结局指标
主要结局
bleeding complication
时间窗: 4 weeks postoperatively
proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding
次要结局
- bleeding volume(the actual time of surgery)
- proportion of other postoperative complications(4 weeks postoperatively)
- surgical difficulty(the actual time of surgery)
- surgery time in minutes(the actual time of surgery)
研究者
Krister Johansson
Dr Krister Johansson. Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University
Malmö University