Short summary

The study is a prospective cohort study which aims to examine whether the ROTEM system is of advantage in the management of patients with acute upper gastrointestinal bleeding. By using the ROTEM analysis as guidance in the managment of our cohort, instead of present algorithms, we seek to decrease the re-bleedingrate and thereby improving the prognosis.

Rationale

Background and aims: Acute upper gastrointestinal bleeding (AUGIB) is a frequent cause of hospital admission and is associated with a mortality of 10%. 40 % of the AUGIB-patients have bleeding peptic ulcer as a cause. The frequency regarding death- and re-bleeding rate has not changed for decades. It is therefor important to investigate and search for alternative treatment methods. Among a variety of important factors, a defect in the blood-clotting system has shown a significant impairment of the prognosis. Approximately 16% of the AUGIB patients have a defect in their blood-clotting system. It is of great interest to identify these patients and thereby decrease e.g. the re-bleeding rate to improve the prognosis. It is possible to detect coagulopathy by means of Rotational trombolestography (ROTEM). With ROTEM it is possible to make a bed-side analysis, where defects in the blood-clotting system can be identified. However the method works better with critically ill patients with a large blood loss. A score system, the Glascow Blatchford score > 2, is used to categorize this group with large blood loss. The ROTEM analyzes the blood-sample faster and gives a more detailed overview of possible deficiencies. With ROTEM the endoscopic knows exactly which component of the blood the patient lacks and can treat the patient more precisely compared to present algorithms in which a fixed ratio of blood components is used. The aim of this study is to examine whether the ROTEM system is of advantage in the management in patients with a acute upper GI-bleeding.

Methods: 150 patients with significant upper gastrointestinal bleeding and a Glasgow Blatchford score > 2. For each patient 2 ROTEM analyses will be made. 15 % of the patients are expected to have 3 further analyses. Defects in coagulation will be corrected. Numbers of patients with coagulation defects, re-bleeding, interventions and mortality will be registered and compared to that of historical controls.

Description of the cohort

Our patient cohort includes all patients over age of 18 admitted to FAM Odense (Fælles Akut Modtagelse) with significant upper gastrointestinal bleeding and a Glasgow Blatchford score > 2.

Data and biological material

There will be collected a blood sample to run each ROTEM analysis. The blood sample will be destroyed immediately after the analysis.

Furthermore following data will be collected: Patient characteristics (age, gender, medicine list, diagnosis, comorbidities and Glascow Blatchford score), laboratory test results (B-hgb, conventional coagulation parameters and other relevant lab tests), ROTEM test results and a number of outcomes (number and type of coagulopathy, re-bleedings, endoscopic procedure performed, type and number of blood transfusions and medication used in order to stabilize the patient and other relevant parameters).

Collaborating researchers and departments

Department of Medical Gastrointestinal Diseases, Odense University Hospital

• Medical Student, Zerin Khalaf

Department of Clinical Immunology, Odense University Hospital

• MD Mette Andersen Reeh