Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
Direct oral anticoagulants (DOACs) are increasingly used, but evidence on bleeding risk during oral soft tissue biopsy is limited. This prospective case-control study compared intraoperative, perioperative, and postoperative bleeding in 50 patients on uninterrupted DOAC therapy versus 50 anticoagulant-naive controls undergoing standardized oral soft tissue biopsy with suturing. All bleeding events were managed with local haemostatic measures. The study aims to determine whether DOAC continuation is safe for this procedure.
详细描述
This monocentre prospective case-control study will be conducted at the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, Italy. It will enrol
- DOAC group (n=50): uninterrupted apixaban, rivaroxaban, edoxaban, or dabigatran.
- Control group (n=50): no anticoagulant therapy.
Bleeding will be assessed in patients treated for excisional soft tissue biopsy under local anaesthesia (mepivacaine with vasoconstrictor) and closure with 4-0 resorbable sutures. Bleeding will be classified as:
- Intraoperative (during procedure)
- Perioperative at 20, 40, 60, and 80 minutes post-procedure
- Postoperative by patient diary from day 1 to day 7 (T1-T7) Local haemostatic measures (tranexamic acid-soaked gauze, resuturing, diathermocoagulation) will be applied as needed. DOACs will not be interrupted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •capacity to understand and sign informed consent;
- •documented indication for oral soft tissue biopsy
排除标准
- •inability to provide consent;
- •congenital or acquired coagulopathy (including haemophilia, von Willebrand disease, thrombocytopenia, or hepatic cirrhosis);
- •active antiplatelet therapy other than low-dose aspirin
研究组 & 干预措施
DOAC Group
patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran)
Control Group
patients not receiving any anticoagulant therapy
结局指标
主要结局
Intraoperative bleeding
时间窗: duration of the intervention
bleeding during the surgical procedure causing inadequate visualisation of the operative field and requiring active haemostatic intervention (gauze compression, diathermocoagulation, or haemostatic agents)
Perioperative bleeding (immediate postoperative)
时间窗: 80 minutes
persistent oozing or frank bleeding within 80 minutes of procedure completion that could not be controlled by standard gauze compression alone. Assessed dichotomously (present/absent) at 20, 40, 60, and 80 minutes post-procedure. If bleeding is detected at 20 minutes, tranexamic acid-soaked gauze will be applied; if bleeding persists at 40 minutes, resuturing or diathermocoagulation will be performed.
Postoperative bleeding
时间窗: 7 days
any bleeding beyond 8-12 hours from procedure completion, recorded daily by patients in a clinical diary from day 1 (T1) to day 7 (T7) and graded as: absent; mild (manageable with gauze/tranexamic acid at home); moderate (exuberant clot formation or bleeding requiring outpatient review).
次要结局
未报告次要终点
研究者
Rossana Izzetti
Researcher
University of Pisa