Recruiting

Study on the Effects of Rivaroxaban in Patients with Short Bowel Syndrome on Long-Term Parenteral Nutrition

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication rivaroxaban, known by the brand name Xarelto, in patients with short bowel syndrome. Short bowel syndrome is a condition where a significant portion of the small intestine is missing or not functioning properly, often requiring patients to rely on long-term intravenous feeding, known as parenteral nutrition. The purpose of the study is to evaluate the clinical and laboratory outcomes of using rivaroxaban in these patients.

Participants in the study will take rivaroxaban, which is a medication used to prevent blood clots, in the form of film-coated tablets. The study will observe the effects of this medication over a period of at least one year. During this time, researchers will monitor the participants' health outcomes, such as the occurrence of blood clots or bleeding events, and compare these with laboratory tests that measure the levels of rivaroxaban in the blood. The study will also assess the quality of life of the participants using a standard questionnaire.

The study aims to provide valuable insights into how rivaroxaban affects patients with short bowel syndrome who are dependent on long-term parenteral nutrition. By understanding the relationship between the medication's blood levels and clinical outcomes, the study hopes to improve treatment strategies for these patients. The research will also explore how different individuals absorb the medication, which can vary from person to person.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: diagnosis of short bowel syndrome or intestinal malabsorption, current use of total parenteral nutrition, age 18 or over, and a need for anticoagulant therapy.
Step 2
Medication administration
The medication used in this study is Xarelto, which contains the active substance rivaroxaban. It is administered orally in the form of a 20 mg film-coated tablet.
The frequency and duration of administration are determined by the study protocol and the patient's specific medical needs.
Step 3
Monitoring and assessments
Throughout the study, clinical outcomes are monitored, focusing on the effectiveness and safety of the treatment. This includes checking for venous thromboembolism, cerebrovascular stroke, and any major bleeding events.
Laboratory assessments are conducted to measure the absorption of rivaroxaban and its correlation with anti Xa levels.
Step 4
Quality of life evaluation
Participants' quality of life is assessed using the SF-36 questionnaire, which evaluates various health-related aspects.
Step 5
Study duration
The study is designed to last for at least one year, with the primary focus on clinical outcomes and laboratory assessments over this period.

Who can join the trial?

4 criteria

Have a diagnosis of short bowel syndrome or intestinal malabsorption. This means the intestine is shorter than normal or doesn't absorb nutrients well, and this must be diagnosed by a specialist doctor.
Currently using Total Parenteral Nutrition (TPN). This is a way of getting nutrition through a vein when the digestive system can't be used.
Be 18 years old or older.
Need to use anticoagulant therapy before starting TPN. This includes medications like DOAC, vitamin K antagonists, or heparin, which help prevent blood clots. Reasons for needing these medications might include preventing strokes in people with atrial fibrillation (an irregular heartbeat) or preventing blood clots in veins.

Who cannot join the trial?

6 criteria

Patients who do not have short bowel syndrome cannot participate. Short bowel syndrome is a condition where part of the small intestine is missing or not working properly.
Patients who are not receiving long-term parenteral nutrition cannot participate. Parenteral nutrition is a way of getting nutrition into the body through the veins.
Patients who are not taking rivaroxaban cannot participate. Rivaroxaban is a medication used to prevent blood clots.
Patients younger than 3 years old or older than 4 years old cannot participate.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not automatically excluded. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities, but this study does not specifically exclude them.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Rivaroxaban is a medication used in this study to evaluate its effects on patients with short bowel syndrome who rely on long-term parenteral nutrition. The study aims to assess the clinical outcomes of these patients when taking rivaroxaban and to compare these outcomes with laboratory assessments. Rivaroxaban is typically used to prevent blood clots, and in this trial, its role is to determine how it affects patients' health over an extended period.

Rivaroxaban

What is already known about the treatment

Rivaroxaban – Rivaroxaban is an oral medication typically administered in tablet form. It is currently being studied for its effects on patients with short bowel syndrome who rely on long-term parenteral nutrition. The main therapeutic indication for rivaroxaban is to prevent blood clots, as it is classified as an anticoagulant. At the molecular level, rivaroxaban works by inhibiting Factor Xa, an essential component in the blood clotting process, thereby reducing the risk of clot formation.

Investigated diseases

Short Bowel Syndrome – This condition occurs when a significant portion of the small intestine is missing or has been surgically removed, leading to difficulties in absorbing nutrients. As a result, individuals may experience malnutrition, diarrhea, and dehydration. The body struggles to absorb vitamins, minerals, and fluids, which can lead to weight loss and fatigue. Over time, the remaining intestine may adapt to improve nutrient absorption, but this process can vary greatly among individuals. Patients often require specialized nutritional support, such as parenteral nutrition, to maintain adequate nutrition.