SIMPLE LAB TEST FOR LOCALIZING GI BLEEDING SITE

胃肠道出血是一个主要的临床问题。出血可能是急性和严重的，也可能是慢性的和未被注意到的(即隐性出血)。急性出血是一种医疗紧急情况，需要立即评估和治疗。隐性出血可能是结肠癌的征兆，需要仔细评估，以避免错过可治愈阶段的癌症。在任何一种类型的胃肠道出血的医疗处理中，最初也是重要的一项决定是将出血部位定位于上消化道或下消化道。在这个项目的第一阶段，我们开发了一种简单的体外测试来分析粪便样本中的血液。这项测试旨在从粪便样本中确定出血是来自上消化道还是下胃肠道部位。这一第二阶段项目的目标是在临床环境中对一大批预期的胃肠道出血患者进行测试，以确认该测试的临床准确性和有效性。拟议的商业应用：该产品将用于急性胃肠道出血患者的临床治疗(约占所有住院患者的2%)0和被发现患有隐性胃肠道出血的患者，占美国人口的5%。主要客户将是胃肠病专家、内科和家庭医生，以及医院、急诊室和诊所。拟议的文书将非常经济，并应在总体资源利用方面产生相当大的节省。经济上的激励和患者的利益将导致商业发展的成功。

Bleeding in the gastrointestinal tract is a major clinical problem. Bleeding may be acute and severe or it may be chronic and unnoticed (i.e. occult bleeding). The acute bleeding is a medical emergency that needs to be evaluated and treated immediately. Occult bleeding may be a sign of colon cancer and demands a careful evaluation to avoid missing a cancer in a curable stage. An initial and important determination in the medical management of either type of gastrointestinal bleeding is the localization of the bleeding site to either the upper or the lower gastrointestinal tract. During the Phase I portion of this project we developed a simple in vitro test for the analysis of blood in stool samples. This test was designed to determine, from a stool sample, whether bleeding was from an upper or lower gastrointestinal site. The objective of this Phase II project is to confirm the clinical accuracy and usefulness of this test with a large prospective group of patients with gastrointestinal bleeding in a clinical environment. PROPOSED COMMERCIAL APPLICATIONS: This product will be used in the clinical management of patients with acute GI bleeding (about 2% of all hospitalized patients0 and patients found to have occult GI bleeding, as much as 5% of the population in the United States. The primary customers will be gastroenterologists, internal medicine and family practice physicians, as well as hospitals, emergency rooms and clinics. The proposed instrument will be very economical and should result in quite large savings in overall resource utilization. The economical incentive along with patient benefit will result in a successful commercial development.