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Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period

A legfontosabb adatok

Ki végzi
Hospices Civils de Lyon
Hol
Franciaország3 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
279 fő, tervezett
Kezdés
2026. júl. 1.
Várható befejezés
2030. júl. 1.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • blood sampling
  • Biocollection
A regiszteradat frissítve
2026. június 17.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with severe liver disease who are waiting for a liver transplant and then receive it. Blood samples are taken to help predict infection risk soon after the transplant.

Életkor
18 years and older
Nem
All sexes
A betegség stádiuma
Waiting for a liver transplant because of one of these: compensated cirrhosis (liver scarring) with hepatocellular carcinoma (liver cancer); chronically decompensated cirrhosis (for example repeated gut bleeding, fluid in the belly that does not respond to treatment, brain problems from liver disease, chronic liver failure); acute decompensated cirrhosis, with or without failure of other organs (ACLF); or acute fulminant hepatitis (sudden severe liver failure). People must receive the transplant and give a blood sample on the day of the transplant.
Korábbi kezelés
People cannot have had immunosuppressive therapy (medicine that weakens the immune system) before the transplant. Corticosteroids at 40 mg per day for alcoholic hepatitis are allowed. No other immune-changing therapy, such as immune checkpoint inhibitors, before the transplant.

A részvétel fő kizáró okai

  • People under 18
  • Pregnant or breastfeeding women
  • Waiting for a transplant of more than one organ at once
  • Under legal guardianship or conservatorship, or deprived of liberty
  • Not enrolled in the social security system

Ez a vizsgálat csak szervátültetésen átesett résztvevőket keres. A regiszter mondata, amelyen ez alapul: Patients receiving LT AND

A regiszter feltételei, szó szerint

Mind a 17 feltétel megnézéseKevesebb

Ki vehet részt

  • Patients awaiting liver transplantation for one of the following indications:
  • Compensated cirrhosis complicated by hepatocellular carcinoma
  • Chronically decompensated cirrhosis (recurrent gastrointestinal bleeding, refractory ascites, portopulmonary or hepatopulmonary syndrome, hepatic encephalopathy, chronic liver failure)
  • Acute decompensated cirrhosis, with or without associated multiple organ failure (ACLF)
  • Acute fulminant hepatitis; Final inclusion will be :
  • Patients receiving LT AND
  • Who provided their consent to participate during the initial enrollment visit AND
  • For whom the baseline sample (during the day of the LT) was collected

Ki nem vehet részt

  • Patients receiving immunosuppressive therapy prior to LT (with the exception of corticosteroids at a dosage of 40 mg per day for the treatment of alcoholic hepatitis)
  • Patient who is a candidate for a combined organ transplant
  • Patient receiving other immunomodulatory therapy (such as immune checkpoint inhibitors) prior to LT
  • Minors
  • Patients under legal guardianship or conservatorship
  • Pregnant or breastfeeding women
  • Patients deprived of their liberty
  • Patients not enrolled in the social security system
  • Refusal to participate in the study

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases.

A teljes eredeti leírásKevesebb

The expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (< 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score > 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival.

PREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.

A vizsgálat csoportja

  • Patients with severe liver disease waiting for liver transplantation (LT)

    Only patients with the most frequent Liver transplantation (LT) indications will be eligible: complicated cirrhosis of hepatocellular carcinoma (HCC), acute or chronic decompensation of cirrhosis, with or without multi-visceral and fulminant hepatitis

    Kezelés: blood sampling és Biocollection

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2026. június 17.