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Peri-operative rATG-perfusion of Solid Transplants

NCT ID: NCT03377283

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-17

Study Completion Date

2016-02-24

Brief Summary

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The increasing demand for organ transplantation and the shortage of available organs limit the success of organ transplantation programs. Consequently, acceptance of expanded criteria donor (ECD) organs with the consequences of higher risk of unfavorable transplantation outcome has become an increasing reality. Among the most prominent characteristics distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI). Currently there are no standard regimens to improve the quality of ECD organs. Therefore, donor organ treatment might be a promising approach to substantially improve organ quality. It will be investigated whether the application of the peri-operative perfusion of kidneys and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.

This trial is designed as a parallel armed randomized controlled trial.

Detailed Description

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Conditions

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Organ Preservation Solutions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AP-KTx/LTx

Transplant recipients receiving an rATG-perfused kidney or liver

Group Type ACTIVE_COMPARATOR

organ perfusion with rabbit anti-thymocyte globulin (rATG)

Intervention Type BIOLOGICAL

CP-KTx/LTx

Transplant recipients receiving a control-perfused kidney or liver.

Group Type PLACEBO_COMPARATOR

organ perfusion with saline

Intervention Type OTHER

Interventions

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organ perfusion with rabbit anti-thymocyte globulin (rATG)

Intervention Type BIOLOGICAL

organ perfusion with saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients receiving a kidney or liver transplant from deceased donors

Exclusion Criteria

* Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Katja Kotsch

Univ. Prof. Dr. Katja Kotsch

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Ritschl PV, Gunther J, Hofhansel L, Kuhl AA, Sattler A, Ernst S, Friedersdorff F, Ebner S, Weiss S, Bosmuller C, Weissenbacher A, Oberhuber R, Cardini B, Ollinger R, Schneeberger S, Biebl M, Denecke C, Margreiter C, Resch T, Aigner F, Maglione M, Pratschke J, Kotsch K. Graft Pre-conditioning by Peri-Operative Perfusion of Kidney Allografts With Rabbit Anti-human T-lymphocyte Globulin Results in Improved Kidney Graft Function in the Early Post-transplantation Period-a Prospective, Randomized Placebo-Controlled Trial. Front Immunol. 2018 Aug 24;9:1911. doi: 10.3389/fimmu.2018.01911. eCollection 2018.

Reference Type DERIVED
PMID: 30197644 (View on PubMed)

Other Identifiers

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UN4640

Identifier Type: -

Identifier Source: org_study_id