HematemesisPOCGIBNCT03028064
Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding
An observational study of Hematemesis and Melena, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematemesis, Melena, Gastrointestinal Hemorrhage
- What is being tested?
- blood taking
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)
Who may be able to join
- patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)
Who cannot join
- asymptomatic patients with anemia are absence of positive gastroscopic findings to support gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- blood taking
- Medical subject headings
- Hematemesis, Melena, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood takingOther
in this cohort study, we will take blood to examine the platelet function
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 30 days of trial inclusion
Secondary outcomes (1)
All cause deaths, cardiovascular or cerebral thrombotic events
All cause deaths, cardiovascular or cerebral thrombotic events
Measured: within 30 days of trial inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematemesisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028064
- Sponsor's protocol ID
- POCGIB
- Acronym
- POCGIB
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03028064
- Acronym / sponsor ID
- POCGIB / POCGIB
- Conditions
- Hematemesis, Melena, Gastrointestinal Hemorrhage, Platelet Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)
Key inclusion criteria (1 listed)
- patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)
Key exclusion criteria (1 listed)
- asymptomatic patients with anemia are absence of positive gastroscopic findings to support gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood takingin this cohort study, we will take blood to examine the platelet function | Other | – |
Primary outcome
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
1 secondary outcome
All cause deaths, cardiovascular or cerebral thrombotic events
Time frame: within 30 days of trial inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hematemesis
Recruiting
A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB
Melena, Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematemesis and Melena, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active bleeding that requires interventions (endoscopic, radiologic or surgery) (time frame: within 30 days of trial inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.