Immune Function as Predictor of Infectious Complications and Clinical Outcome in Patients Undergoing Solid Organ Transplantation

NCT03847285 | Active Not Recruiting DMC

• 1 other identifier: sponsor - rigshospitalet
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

At Rigshospitalet, Denmark, we will examine the immune function of solid organ transplant recipients before and at several timepoints after transplantation as well as the clinical outcome, especially the risk of infections complications and graft rejections. The immune function will be assessed with a complete immunological profiling consisting of immune phenotype (flow cytometry), immune function (TruCulture®) and circulating biomarkers. The study aims to generate prediction models of patients at excess risk of poor clinical outcome, with the ultimate intent to propose personalized immunosuppressive regimes to be tested in future randomized clinical trials.

Conditions

Transplant

Keywords

Transplant; Infection; rejection; immunology

Outcome Measures

Primary Outcomes (2)

• Infection

  Infections (viral, bacterial or fungal) within 1 year after the transplantation

  one year

• graft rejection

  Graft rejection within 1 year after the transplantation. Rejections will be defined by pathologist and clinician.

  one year

Secondary Outcomes (4)

• combined endpoints at 28 days post transplantation

  28 days

• combined endpoints at 90 days post transplantation

  90 days

• combined endpoints at 2 years post transplantation

  2 years

• combined endpoints at 5 years post transplantation

  5 years

Interventions

solid organ transplantation OTHER

solid organ transplantation: kidney, heart, pancreas, lung and liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must have a planned kidney, heart, lung, liver or pancreas transplant or be on the waiting list for a heart, lung, liver or pancreas-transplantation at Rigshospitalet, Denmark

You may qualify if:

• To be eligible for the study the participant must be a minimum of 18 years of age, participate in the PERSIMUNE biobank, have a planned kidney, heart, lung, liver or pancreas transplant or be on the waiting list for a heart, lung, liver or pancreas transplant and be able to sufficiently understand oral and written study information in Danish or English to provide an informed consent. Study participation is strictly voluntary

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Drabe CH, Sorensen SS, Rasmussen A, Perch M, Gustafsson F, Rezahosseini O, Lundgren JD, Ostrowski SR, Nielsen SD. Immune function as predictor of infectious complications and clinical outcome in patients undergoing solid organ transplantation (the ImmuneMo:SOT study): a prospective non-interventional observational trial. BMC Infect Dis. 2019 Jul 3;19(1):573. doi: 10.1186/s12879-019-4207-9.

  PMID: 31269923 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma

MeSH Terms

Conditions

Infections; Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Susanne Dam Nielsen, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, clinical professor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 20, 2019
• Study Start: April 1, 2018
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

DK (1)