Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding

Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source Chinese University of Hong Kong
Brief Summary

Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing population, antiplatelet drugs are increasingly being prescribed for treatment and prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function should be integral in the management plan. A quantitative measurement allows titration of platelet function in accordance with bleeding or thromboembolic risk. Platelet function has not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As a first step, the study will determine if platelet dysfunction is associated with clinical outcome. In this prospective, observational single centre cohort study of consecutive patients with overt signs of acute upper gastrointestinal bleeding, their platelet function by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30 days after trial enrollment. The primary endpoint is defined as significant bleeding that requires interventions (endoscopic, radiologic or surgery). Secondary end points include cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if individual test can distinguish between patients with and without primary end point. This study aims to evaluate the capability of platelet function tests to predict clinical outcome in patients with AUGIB. Logistic regression models will then be built in search for independent correlates to the primary and secondary endpoints and to adjust for confounding variables.

Overall Status Completed
Start Date 2017-01-03
Completion Date 2019-12-01
Primary Completion Date 2019-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Active bleeding that requires interventions (endoscopic, radiologic or surgery) within 30 days of trial inclusion
Secondary Outcome
Measure Time Frame
All cause deaths, cardiovascular or cerebral thrombotic events within 30 days of trial inclusion
Enrollment 476
Condition
Intervention

Intervention Type: Other

Intervention Name: blood taking

Description: in this cohort study, we will take blood to examine the platelet function

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability) Exclusion Criteria: - asymptomatic patients with anemia are absence of positive gastroscopic findings to support gastrointestinal bleeding.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

100 Years

Healthy Volunteers:

No

Location
Facility: Endoscopy Centre
Location Countries

China

Verification Date

2020-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: James Yun-wong Lau

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Acronym POCGIB
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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