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Assessment of natural Immunoglobulin M/AIM Deficiency in Thoracic Transplantation

Assessment of natural Immunoglobulin M/AIM Deficiency in Thoracic Transplantation - AIM-TTX

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038254
Enrollment
200
Registered
2025-12-02
Start date
2025-12-04
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.0 I50.1 J84.1 J44.9

Interventions

Group 1: In patients who have undergone heart or lung transplants, the concentration of immunoglobulin M (IgM) in serum is determined at a maximum of 17 points in time (before surgery, immediately aft

Sponsors

Universitätsklinikum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with terminal heart and/or lung failure who are receiving an isolated heart transplant or an isolated lung transplant - Age = 18 years - Written informed consent from the patient

Exclusion criteria

Exclusion criteria: - Age < 18 years - Lack of consent - Combined procedure (multiple organ transplant) - Re-transplantation

Design outcomes

Primary

MeasureTime frame
Prevalence of clinically relevant immunoglobulin M deficiency (immunoglobulin M serum concentration < 0.8 g/L)

Secondary

MeasureTime frame
- MACCE (major adverse cardiac and cerebrovascular event), defined as hospital mortality, myocardial infarction, reoperation/reintervention, stroke, occurrence of sepsis/SIRS) - Postoperative serum concentration of calcineurin inhibitors (especially tacrolimus) - Primary graft dysfunction (ISHLT definition for heart and lung transplantation) - Acute rejection (ISHLT definition for heart and lung transplantation)

Countries

Germany

Contacts

Public ContactMoritz B. Immohr

Universitätsklinikum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie

moritz.immohr@uk-essen.de+49 201 723 86133

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026