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临床试验/NCT02120170
NCT02120170Unknown不适用

The Effect of Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation: Prospective Randomized Controlled Trial

Soonchunhyang University Hospital2 个研究点 分布在 2 个国家目标入组 356 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
356
试验地点
2
主要终点
Number of participants with delayed bleeding

研究概览

简要总结

There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin.

This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.

The enrolled subjects are the patients who take warfarin for high thromboembolism risk and should take heparin bridging therapy during colon polypectomy instead of temporary stopping warfarin. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy.

The primary endpoint is to compare the rate of delayed bleeding between two groups.

详细描述

The American guideline have recommended that if the patient with low risk of thromboembolism, warfarin consumption can be quit 3~5 days before colon polypectomy and resume within 24 hours after polypectomy. However, if the patient were high risk of thromboembolism, the patient should take heparin bridging therapy during temporal quit of warfarin consumption for colon polypectomy. There have been very limited evidences about the bleeding complication during colon polypectomy for the patients with warfarin taking.

Moreover, there have been lack of evidence that how to prevent the bleeding complication in the patients with high risk of thromboembolism who should take heparin bridging therapy during temporal stopping of warfarin for colon polypectomy.

This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.

The investigators will enroll the subjects who should take heparin bridging therapy (quit warfarin 3~5 days before colon polypectomy and check the INR, if the INR <2, heparin or low molecular heparin should be start. If the INR <1.5 on the day before colon polypectomy, the patient will undergo bowel preparation and colon polypectomy. Warfarin will resume within 24 hour after polypectomy) after quit warfarin for during colon polypectomy over 19 years old.

Exclusions are as follow; patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy. Including polyps for colon polypectomy are 6~ 20 mm size and polypectomy procedure is defined as EMR after injection with blended electrical current.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects who should take heparin bridging therapy after quit warfarin 3~5 days before colon polypectomy because of high risk of thromboembolism - AF with valvular disease, AF with mechanical valve, AF with CHF, EF <35%, AF with previous thromboembolism, AF with DM and HTN, AF with old age(>75),

排除标准

  • patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies.

研究组 & 干预措施

Hemoclipping during colon polypectomy for all lesion

Active Comparator

The enrolled patients of group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding.

干预措施: Colon polypectomy (Procedure)

No hemoclipping if there were no bleeding during polypectomy

No Intervention

The patients of group 2 will be performed hemoclipping only for the immediate bleeding during colon polypectomy

结局指标

主要结局

Number of participants with delayed bleeding

时间窗: Bleeding within 30 days after colon polypectomy

The primary endpoint is to compare the rate of delayed bleeding between two groups.

次要结局

  • Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin.(Bleeding during the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyun Gun, Kim. M.D., Ph.D.

Associate professor

Soonchunhyang University Hospital

研究点 (2)

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