Trial record 3 of 9 for:
"Hematemesis"
Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding (POCGIB)
This study is currently recruiting participants.
Verified January 2017 by James Yun-wong Lau, Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03028064
First received: January 13, 2017
Last updated: January 18, 2017
Last verified: January 2017
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Purpose
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 | Intervention |
|---|---|
| Hematemesis Melena Gastrointestinal Hemorrhage Platelet Dysfunction | Other: in this cohort study, we will take blood to examine the platelet function |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding |
Resource links provided by NLM:
Further study details as provided by James Yun-wong Lau, Chinese University of Hong Kong:
Primary Outcome Measures:
- 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:
- All cause deaths, cardiovascular or cerebral thrombotic events [ Time Frame: within 30 days of trial inclusion ]
| Estimated Enrollment: | 476 |
| Study Start Date: | January 2017 |
| Estimated Study Completion Date: | April 2020 |
| Estimated Primary Completion Date: | April 2020 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
| 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03028064
Please refer to this study by its ClinicalTrials.gov identifier: NCT03028064
Contacts
| 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
| 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
More Information
| Responsible Party: | James Yun-wong Lau, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT03028064 History of Changes |
| Other Study ID Numbers: |
CREC2016.282 |
| Study First Received: | January 13, 2017 |
| Last Updated: | January 18, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Hemorrhage Gastrointestinal Hemorrhage Hematemesis Pathologic Processes Gastrointestinal Diseases |
Digestive System Diseases Vomiting Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on July 14, 2017


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