Efficacy of feracrylum and tranexamic acid as topical hemostatic agent in patients taking oral antiplatelets undergoing dental extraction
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and
研究概览
简要总结
Topical haemostatic agents are essential in controlling bleeding during tooth extractions. Common agents include oxidized regenerated cellulose, collagen-based products, fibrin sealants, and chitosan-based dressings, each promoting clot formation through different mechanisms. However, these traditional agents have limitations such as poor antimicrobial activity, longer application time, high cost, or hypersensitivity risks.
Among newer options, Feracrylum and Tranexamic acid are particularly effective, especially for patients on antiplatelet therapy.
- Feracrylum, a synthetic polymer from polyacrylic acid, forms a bioadhesive gel that stabilizes clots and has antibacterial properties, reducing infection risk. It is non-toxic, biocompatible, and suitable for patients with systemic conditions like diabetes or hypertension.
- Tranexamic acid, a synthetic lysine analog, acts as an antifibrinolytic by preventing fibrin breakdown, thereby stabilizing the clot. It is highly beneficial for patients with increased fibrinolytic activity or systemic bleeding risk, offering effective local haemostasis without systemic side effects.
Both agents have shown proven efficacy in clinical studies, making them valuable choices for managing haemorrhage in dental extractions—Feracrylum for its combined antibacterial and haemostatic effects, and Tranexamic acid for its strong clot-stabilizing action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for this study were those aged 18 years or older who consented to participate in the trial.
- •All participants were required to be on a regular regimen of low-dose aspirin (75-100 mg/day) or clopidogrel (75 mg/day) for primary prevention of cardiac complications.
- •Additionally, the study focused on medically compromised patients who were deemed fit for simple extractions under local anaesthesia.
- •Participants needed to have a bleeding time between 2 and 5 minutes, an Activated Partial Thromboplastin Time (APTT) of 30-40 seconds, and an International Normalized Ratio (INR) between 1.0 and 2.5, ensuring they had adequate blood coagulation parameters for safe surgical intervention.
- •Finally, the study included patients who required simple tooth extractions, making them suitable candidates for the haemostatic treatments being evaluated.
排除标准
- •Patients with the following conditions were excluded from the study to ensure the safety and validity of the results.
- •Individuals under the age of 18 were excluded, as well as those who did not consent to participate.
- •Patients who had an allergy to local anaesthetics or their constituents were also excluded, as this could interfere with the surgical procedure.
- •Those with liver disease, or who were on combination antiplatelet drugs or NSAIDs that might interact with aspirin, were excluded due to the potential impact on bleeding risk and drug interactions.
- •Additionally, patients with a history of serious haemorrhage following dental extractions were not included, as they might have an increased risk of complications.
- •Patients who had discontinued antiplatelet medications prior to the procedure were also excluded.
- •Other exclusion criteria included systemic conditions where tooth extraction is contraindicated, such as uncontrolled diabetes or hypertension, cancers like leukaemia or lymphoma, recent myocardial infarction or stroke (within the past 6 months), and blood disorders like haemophilia.
- •Patients with end-stage renal disease, pregnant women in the 1st and 3rd trimesters, or those who had previously undergone radiation therapy in the extraction region were also excluded.
- •These exclusions ensured that the study population was free from confounding factors that could compromise the outcomes or complicate the healing process.
结局指标
主要结局
Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and
时间窗: Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and | clopidogrel.
clopidogrel.
时间窗: Assessing the of efficacy of feracrylum and tranexamic acid as topical haemostatic agent in patients taking antiplatelets drugs undergoing dental extraction without stopping aspirin and | clopidogrel.
次要结局
未报告次要终点
研究者
Iniya Shree
Meenakshi Ammal Dental College and Hospital