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Completed

NCT Number: NCT03028064

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Centre

Hong Kong, HONG KONG, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood taking

Other

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

Primary outcomes

  1. Active bleeding that requires interventions (endoscopic, radiologic or surgery)

    Time frame: within 30 days of trial inclusion

    Data on whether patients experience further bleeding that requires interventions, the type of interventions and the time of further bleeding after trial inclusion, will be collected through electronic medical record

Secondary outcomes

  1. All cause deaths, cardiovascular or cerebral thrombotic events

    Time frame: within 30 days of trial inclusion

    All cause deaths, cardiovascular or cerebral thrombotic events

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: POCGIB

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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