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

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ClinicalTrials.gov Identifier: NCT03028064
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, 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.

Condition or disease Intervention/treatment
Hematemesis Melena Gastrointestinal Hemorrhage Platelet Dysfunction Other: blood taking

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Study Type : Observational
Estimated Enrollment : 476 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: blood taking
    in this cohort study, we will take blood to examine the platelet function


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028064


Contacts
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Contact: James Y Lau, MD +852 2632 ext 1411 laujyw@surgery.cuhk.edu.hk
Contact: Karina Yu, PhD +852 2632 ext 2931 karinayu@surgery.cuhk.edu.hk

Locations
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China, Hong Kong
Endoscopy Centre Recruiting
Hong Kong, Hong Kong, China
Contact: James Y LAU, Prof    +852 2632 ext 1411    laujyw@surgery.cuhk.edu.hk   
Contact: Karina Yu, PhD    +852 2632 ext 2931    karinayu@surgery.cuhk.edu   
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03028064     History of Changes
Other Study ID Numbers: POCGIB
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Hematemesis
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms