CTRI/2021/03/032465尚未招募1/2 期
A comparative study to assess bleeding with or without discontinuing antiplatelettherapy in patients undergoing dental extraction.
Dimple Chandra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月4日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
| Antiplatelet drugs are used for the primary and secondary prevention of cardiovascular events and cerebrovascular disease, especially in patients with ischemic heart disease, a history of coronary artery bypass previous myocardial infarction, placement of a stent, non-hemorrhagic stroke, peripheral arterial disease, and transient ischemic attacks. The most commonly prescribed antiplatelet drugs are aspirin and clopidogrel, used as single therapy or in combination. Aspirin is non-steroidal anti-inflammatory drug that exhibits analgesic, antipyretic, anti-inflammatory properties. Its Mechanism of action involves an irreversible inhibition of cyclooxygenase, which is responsible for the conversion of arachidonic acid into prostaglandins, prostacyclin, and thromboxane. Evidence suggests that a 75–100 mg daily dose of aspirin is optimal for the long-term prevention of serious vascular events in high-risk patients. Clopidogrel is an antiplatelet drug causing irreversible inhibition of an adenosine diphosphate receptor (P2Y12) important in promoting platelet aggregation and cross-linking of platelets by fibrin. The dosage used is 75–100 mg/day, with a half-life of 8 h. Many patients receive a combination of antiplatelet drugs, e.g. aspirin and clopidogrel 4–6; this has been shown to have a synergistic antiplatelet action, with the risk of bleeding complications much greater for combined therapy than for single-drug therapy. |
The fear of uncontrolled or excessive bleeding has prompted dental practitioners to cease or alter the use of these drugs before extraction. Several studies have demonstrated the risk of thrombosis and myocardial infarction after withdrawal of antiplatelet drugs.
PROCEDURE OF STUDY :
ï‚· Ethical clearance will be obtained from Institutional Ethical Review Board.
ï‚· The study will be explained to the subjects and an informed consent for the
study will be obtained from them.
|  The written consent will be obtained from their respective physician.  The study population will be randomly divided into two groups: o Group A o Group B. GROUP A: Antiplatelet therapy will be continued before and after extraction. GROUP B: Antiplatelet drugs will be discontinued 4 days before the extraction.  For all the patients of Group A and Group B preoperative bleeding time, clotting time , prothrombin time , and platelet count will be recorded.  Those patients in which these parameters were in normal range will be included in study.  All the participants in Group A will continue their antiplatelet drug therapy prior to extraction.  All the participants in group B discontinued antiplatelet therapy 4 days prior to extraction.  Extractions will be performed with minimal trauma under local anesthesia (2% lignocaine with vasoconstrictor).  Intraoperative bleeding will be measured by “Guaze method†[2x2 inch surgical gauze will be weighed pre and post operatively, and the difference in the weight will be noted. Blood loss will be calculated based on the formula of 1gm = 1ml of blood].  For every patient postoperative bleeding will be assessed after 30 minutes, 1 hour and 24 hours.  After the procedure, a gauze pressure pack will be applied to the extraction socket for 30 minutes and bleeding will be evaluated clinically after 30 minutes.  If bleeding is present fresh pressure pack is reapplied for another 30 minutes and bleeding will be evaluated after that.  If after 1 hour bleeding is noted it will be controlled with the help of hemostatic methods, agents or diathermy.  If after 24 hours bleeding is noted then patient will be hospitalized. |
| ï‚· All Patients will receive 500 mg of amoxycillin thrice a day and 500mg of paracetamol for 3days. ï‚· After the procedure, all the patients will be given a list of instruction about post operative care and a telephone number to call the surgeon in case of emergency. ï‚· All the patients will be examined and questioned for bleeding at the postoperative 24 hour follow-up. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 10.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients on antiplatelet therapy requiring extraction.
- •Patients requiring single or multiple [up to 3] extractions.
- •Patients willing to participate in the study.
- •Patients on antiplatelet therapy for preventive prophylaxis.
排除标准
- •Patients with hematological, renal, or liver disease.
- •Patients with bone marrow disorders or alcoholism.
- •Patients on any concurrent medication affecting hemostasis such as oral or parental anticoagulants.
- •Patient on antiplatelet therapy as secondary prophylaxis
- •Pregnant and lactating women.
- •Patient with medical history which is an absolute contraindication for extraction.
结局指标
主要结局
Intraoperative bleeding
时间窗: 30 minutes , 1 hour
次要结局
- Postoperative duration of bleeding(24 hours)
研究者
研究点 (1)
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