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Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding

This study is looking at a new scoring system, called CAGIB, for people who have liver scarring (cirrhosis) and sudden, serious bleeding in their stomach or intestines. This type of bleeding can be very dangerous. The CAGIB score helps doctors quickly work out how severe a patient's condition is and how likely they are to recover while in hospital. Researchers want to see if the CAGIB score is better than older scores (Child-Pugh and MELD) at predicting how these patients will fare. The aim is to help doctors make quicker, more accurate treatment decisions.

At a glance

Status
Recruiting
Sponsor
Xingshun Qi
Enrolment target
3,000
Start
01 Jan 2022
Estimated completion
01 Dec 2025

What is this study about?

Imagine you have liver scarring, known as cirrhosis, and suddenly start bleeding seriously from your stomach or bowels. This can be a very scary and life-threatening situation. Doctors need to quickly understand how severe your condition is and what your chances are of getting better while in hospital, so they can give you the right treatment as fast as possible.

This is where 'scoring systems' come in. They use information about your health to give a number that helps predict how you might respond. There's a new scoring system called CAGIB, which was developed based on information from many patients in China. Now, doctors from different countries want to check if this new CAGIB score works well for all patients with cirrhosis and this type of bleeding.

The study will compare the CAGIB score with two older, more established scoring systems called Child-Pugh and MELD. By looking at a large group of patients, they aim to see if CAGIB is more accurate at predicting who will recover in hospital and who might sadly not make it. The hope is that if CAGIB proves to be better, it can help doctors around the world make more informed decisions and potentially improve care for patients like you.

Key takeaways

  • A study comparing a new score (CAGIB) to older ones.
  • Aims to predict outcomes for liver cirrhosis patients with serious bleeding.
  • Is 'observational' – no new treatments or tests involved.
  • Could help doctors make quicker, better decisions in urgent situations.
  • Participation involves no direct risks or changes to your care.
  • Your data could help improve future patient care.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older. You must also have a diagnosis of liver scarring, known as cirrhosis. A key requirement is that you are currently experiencing acute gastrointestinal bleeding, which means you have recently had symptoms like vomiting blood, passing very dark, tar-like stools (melena), or passing fresh blood in your stools (hematochezia).

There are a few reasons why someone might not be able to join. For example, if some of the information needed to calculate the special scores (CAGIB, Child-Pugh, and MELD) isn't available from your medical tests. Also, if doctors can't properly follow your health progress or outcomes during your hospital stay, then you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of liver scarring (cirrhosis)?
  3. Are you currently experiencing sudden, serious bleeding from your stomach or bowel?
  4. Are your hospital test results available for doctors to review?
Answer every question to see your result.

What does participation involve?

This is an 'observational' study, which means you wouldn't be given any new treatments or medicines that are different from what your doctor would normally prescribe. Instead, the doctors would simply collect information about your health, your condition, and how you respond to your usual care while you are in hospital. There are no extra hospital visits or long-term follow-up appointments specifically for this study. The study simply involves doctors using the information they already collect as part of your standard hospital care to see how well the different scoring systems work.

Potential risks and benefits

Taking part in this study carries no direct risks to you, as it only involves collecting information from your medical records and does not change your treatment in any way. There are no direct benefits to you as an individual from joining, as you will receive the same high standard of care regardless. However, by allowing your information to be used, you would be helping doctors learn more about how to best treat patients like you in the future, potentially improving care for many others. You are free to withdraw your consent for your information being used at any time without it affecting your medical care.

Locations (23)

  • The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
    Verified postcode
    Scranton, United States· Not yet recruiting
  • São Paulo State University (UNESP), Botucatu Medical School
    Verified postcode
    São Paulo, Brazil· Recruiting
  • Beijing Youan Hospital, Capital Medical University
    Verified postcode
    Beijing, China· Recruiting
  • The Seventh Medical Center of Chinese PLA General Hospital
    Verified postcode
    Beijing, China· Not yet recruiting
  • First Affiliated Hospital of Fujian Medical University
    Verified postcode
    Fuzhou, China· Recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Verified postcode
    Wuhan, China· Recruiting
  • First Affiliated Hospital of Nanchang University
    Verified postcode
    Nanchang, China· Recruiting
  • The Six People's Hospital of Dalian
    Verified postcode
    Dalian, China· Recruiting
  • Air Force Hospital of Northern Theater Command
    Verified postcode
    Shenyang, China· Recruiting
  • General Hospital of Northern Theater Command
    Verified postcode
    Shenyang, China· Recruiting
  • The First Hospital of China Medical University
    Verified postcode
    Shenyang, China· Recruiting
  • The Six People's Hospital of Shenyang
    Verified postcode
    Shenyang, China· Recruiting

Common questions

What is liver cirrhosis?

Liver cirrhosis is when your liver becomes scarred and damaged over a long time, making it difficult for it to work properly.

What is 'acute gastrointestinal bleeding'?

This means sudden, serious bleeding from your food pipe, stomach, or intestines, which can be very dangerous.

What is the CAGIB score?

It's a new tool doctors are testing to help predict how well a patient with liver cirrhosis and stomach bleeding will do in hospital.

Will I get different treatment if I join?

No, this study only collects information. Your treatment will be exactly the same as if you didn't join.

Do I have to do anything extra if I take part?

No, there are no extra tests, visits, or medicines. Doctors just use information from your normal hospital care.

How to find out more

Xingshun Qi, Dr.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Validation of CAGIB Score for In-hospital Mortality of Cirrh…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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