Gastrointestinal Hemorrhage Clinical Trial
Official title:
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02903017 -
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage
|
Phase 4 | |
Recruiting |
NCT02514304 -
Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding
|
||
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT01477320 -
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
|
N/A | |
Not yet recruiting |
NCT01549418 -
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
|
Phase 4 | |
Completed |
NCT02105532 -
Transfusion in Gastrointestinal Bleeding
|
Phase 2/Phase 3 | |
Recruiting |
NCT05226221 -
Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
|
||
Active, not recruiting |
NCT02874326 -
Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber
|
Phase 2 | |
Completed |
NCT02928939 -
Therapeutic Conflicts and Multimorbidity
|
||
Withdrawn |
NCT01215058 -
Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer
|
N/A | |
Completed |
NCT01029626 -
Glasgow-Blatschford Score Validation in Digestive Hemorrhage
|
N/A | |
Completed |
NCT00251979 -
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
|
Phase 3 | |
Completed |
NCT02991612 -
Rifaximin in Patients With Gastroesophageal Variceal Bleeding
|
N/A | |
Recruiting |
NCT02964195 -
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding
|
N/A | |
Terminated |
NCT02609100 -
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy
|
N/A | |
Completed |
NCT02965209 -
European Novel Motorized Spiral Endoscopy Trial
|
N/A | |
Completed |
NCT01872286 -
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
|
N/A | |
Completed |
NCT02349490 -
Seraseal for Endoscopic Hemostasis
|
Phase 4 | |
Withdrawn |
NCT01005147 -
Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding
|
N/A | |
Completed |
NCT00570973 -
Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy
|
Phase 4 |