A RANDOMIZED STUDY OF INJECTION-MULTIPOLAR PROBE COMPARED TO INJECTION-HEMOCL

注射多极探针与注射 HEMOCL 的随机研究

• 批准号: 7606822
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-21 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606822
• 关键词: Acute; Aftercare; Archives; Blood Platelets; Caliber; Case Study; Clip; Combined Modality Therapy; Complication; Computer Retrieval of Information on Scientific Projects Database; Death Rate; Depth; Direct Costs; Educational process of instructing; Endoscopic Hemostasis; Epinephrine; Erythrocytes; Fresh Frozen Plasmas; Funding; Gastrointestinal Hemorrhage; Grant; Healed; Hemostatic function; Hospitals; Injection of therapeutic agent; Institution; Intensive Care Units; Lesion; Non-Malignant; Operative Surgical Procedures; Outcome; Patients; Publications; Purpose; Randomized; Rate; Research; Research Personnel; Resources; Retreatment; Safety; Source; Transfusion; Treatment Failure; Ulcer; United States National Institutes of Health; day; digital video recording; healing; size; upper GI series

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS 1. To compare the efficacy, safety, and convenience of two endoscopic combination therapies (epinephrine injection plus either multipolar probe or hemoclipping) for hemostasis of non-variceal, non-malignant, non-angiomatous, upper GI hemorrhage. 2. To compare ulcer (and lesion) healing (or re-epithelialization) rates at 30 days and 60 days. 3. To quantitate and compare endoscopic lesion sizes (diameter and depth) before vs. immediately after endoscopic treatments; and before endoscopic treatment vs. 30 days. 4. To quantitate and compare routine outcomes after endoscopic hemostasis with the two different treatments, including primary and permanent hemostasis rates; rates of treatment failure and crossover to the other treatment (for failure of acute hemostasis, severe rebleeding necessitating retreatment, or a severe treatment complication); transfusions (units red blood cells, platelets, and fresh frozen plasma- total and post-randomization); duration of hospital and intensive care unit stay; complications; surgery; and death rates at 7 and 30 days and 60 days after randomization. 5. To estimate and compare direct costs of care after randomization of patients. 6. To record, edit, and archive digital images and video clips of study cases for publication and teaching purposes.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 具体目标 1. 比较两种内镜联合治疗（肾上腺素注射+多极探头或血管夹）用于非静脉曲张、非恶性、非血管瘤性上消化道出血止血的有效性、安全性和便利性。 2. 比较30天和60天时的溃疡（和病变）愈合（或上皮再形成）率。 3. 定量并比较内镜治疗前与内镜治疗后即刻以及内镜治疗前与内镜治疗后30天的内镜病变尺寸（直径和深度）。 4. 定量并比较两种不同治疗的内镜止血后的常规结局，包括主要和永久止血率;治疗失败率和交叉至其他治疗的发生率（急性止血失败、需要再次治疗的严重再出血或严重治疗并发症）;输血（单位红细胞、血小板和新鲜冷冻血浆-总量和随机化后）;住院和重症监护室停留时间;并发症;手术;以及随机化后7、30天和60天的死亡率。 5. 估计和比较患者随机化后的直接护理成本。 6. 记录、编辑和存档研究案例的数字图像和视频剪辑，以供出版和教学之用。