Randomized Controlled Trial to Compare Treatment With Oral Anticoagulation With Antagonists of vitaminK vs Low Molecular Weight Heparin(Bemiparin) in Patients With Anticoagulation Criteria and an Episode of Gastrointestinal Bleeding.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rebleeding
研究概览
简要总结
SUMMARY
1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.
1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.
1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with anticoagulation criteria and who have had an episode of gastrointestinal bleeding.
1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr. Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr. Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax: (34) 93 291 92 78.
E-mail: cvillanueva@santpau.es. 1.5. Centers that are planned for the trial: Service Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.
1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor: Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140.
1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main objective: To compare the incidence of gastrointestinal rebleeding and safety of oral anticoagulation versus low molecular weight heparin in patients who have had an acute gastrointestinal bleeding and have indication for anticoagulation.
1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence of gastrointestinal bleeding.
1.14. Study population and total number of patients: 20 patients were required in each group (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and 10% beta.
1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 - July 2013
详细描述
4.c. OBJECTIVES: The main objective of this prospective, randomized study is to evaluate whether the substitution of VKA therapy for low molecular weight heparin (bemiparin) in patients who have had an episode of gastrointestinal bleeding and have the indication for anticoagulant therapy, is associated with a decreased incidence of recurrent gastrointestinal bleeding.
Secondary objectives consist of all of the following:
- Incidence of thromboembolic events
- Bleeding from other locations
- Severity of recurrent episodes of haemorrhagea
- Transfusion requirements
- Identification of risk factors associated
- Mortality
- TYPE OF TRIAL AND DESING.
This is a prospective, randomized, controlled trial, in which patients with gastrointestinal bleeding and indication for anticoagulation will be randomized into two treatment groups:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with anticoagulant treatment criteria (treated with acenocoumarol or warfarin) and high or very high risk of embolism, who have an acute gastrointestinal bleeding (high or low) endoscopically untreatable, secondary to multiple vascular lesions, diverticular origin or unclarified origin (after VGC and DC) who have no exclusion criteria.
排除标准
- •Not be included patients with one or more of the following criteria:
- •A) less than 18 years old. B) pregnancy. C) patient refusal to participate in the study. D) patients in whom the decision has been taken not to provide active treatment for the existence of any clinical situation considered terminal (severe associated diseases evolved).
- •E) Contraindication LMWH (allergy, heparin induced thrombocytopenia). F) bleeding secondary to esophageal varices and / or gastric. G) associated bleeding peptic injury. H) bleeding secondary to tumors or polyps. i) Presence of portal hypertension with or without cirrhosis. J) bleeding due to Mallory-Weiss syndrome. K) anticoagulation for low risk embolic lesions
研究组 & 干预措施
Bemiparin
Group 1 (low molecular weight heparin: bemiparin), which is the study group: after passing the bleeding episode, will receive low molecular weight heparin (bemiparin) in anticoagulant dose. Check should be made by measurement of anti-factor Xa.
干预措施: Bemiparina (Drug)
Warfarin
which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.
干预措施: warfarin (Drug)
结局指标
主要结局
Rebleeding
时间窗: 1 year
upper or lower gastrointestinal bleeding in the follow-up period in both groups.
次要结局
- Time of hospitalization(1 year)
- thromboembolic events(1 year)
- Severity of rebleeding(1 year)
- Mortality:(1 year)
- Association with NSAIDs, aspirin or other antiplatelet agents.(1 year)
- treatment complications.(1 year)
- Number of hospitalizations during follow-up.(1 year)