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

NCT03028064 | Completed

• 1 other identifier: POCGIB
• Study Type: observational
• Target: 476
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematemesis; Melena; Gastrointestinal Hemorrhage; Platelet Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  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

  within 30 days of trial inclusion

Secondary Outcomes (1)

• All cause deaths, cardiovascular or cerebral thrombotic events

  within 30 days of trial inclusion

Interventions

blood taking OTHER

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)

You may not qualify if:

• asymptomatic patients with anemia are absence of positive gastroscopic findings to support gastrointestinal bleeding.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Centre

Hong Kong, HONG KONG, China

Location

MeSH Terms

Conditions

Hematemesis; Melena; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: January 3, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

CN (1)