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van CCT (UK)

van CCT (UK)

The applicability of machine perfusion preservation by the Airdrive system in kidney transplantation.

- candidate number24317
- NTR NumberNTR5847
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mei-2016
- Secondary IDsNL52704.018.15 MEC AMC Amsterdam
- Public TitleThe applicability of machine perfusion preservation by the Airdrive system in kidney transplantation.
- Scientific TitleThe use of the Airdrive machine perfusion system in graft preservation during kidney transplantation a pilot study in kidney transplantation of grafts from post-mortem donors.
- hypothesisIt is safe to use the Airdrive machine perfusion system as a preservation method in kidney transplantation.
- Healt Condition(s) or Problem(s) studiedRenal disease, Renal insufficiency, Renal Replacement Therapies
- Inclusion criteria- Patient has to be at least 18 years of age and mentally competent;
- Voluntary signed and dated Informed Consent Form of the patient has to be obtained prior to any study-specific procedure.
- Exclusion criteriaKidney grafts which are expected to be transplanted within 2 hours after arrival in the AMC, will be excluded to guarantee no extension of cold ischemic times due to Airdrive™ machine perfusion. Estimation of this duration will be done by the transplant surgeon or surgical resident.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-mei-2016
- planned closingdate30-sep-2016
- Target number of participants7
- InterventionsAll seven kidney grafts will be preserved using the Airdrive machine perfusion system between arrival at the AMC and implantation in the recipient instead of continuation of conventional cold storage.
- Primary outcomeThe absence of adverse events due to the use of Airdrive oxygenated machine perfusion as preservation method during kidney transplantation.
- Secondary outcomeRenal function parameters such as serum creatinine and blood urea will be evaluated, as well as histological analyses of a perioperatively harvested graft biopsy.
- TimepointsRenal function parameters will be routinely checked and are all part of the standard patient care protocol of the AMC hospital.
- Trial web siteno
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. dr. T.M. Gulik, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Medical Research B.V.
- PublicationsDoorschodt B.M., et al., Evaluation of a novel system for hypothermic oxygenated pulsatile perfusion preservation. Int J of Artif Organs 32, 728-38 2009
Schreinemachers M.C. et al., Pulsatile perfusion of warm ischaemia damaged experimental kidney grafts. Br. J of Surg 97, 349-358 2010
- Brief summaryKidney donor graft shortage for transplantation has led to the use of marginal donors such as non-heart beating donor (NHBD) kidneys. As perfusion in this category of donor patients is absent prior to graft nephrectomy, NHBD kidneys suffer warm ischemia, causing damage, which is associated with early and late graft loss. Preservation of the graft by hypothermic machine perfusion instead of conventional cold static storage provides a viable solution to reduce the warm ischemic damage-induced graft loss. In preclinical animal studies, the Airdrive™ machine perfusion system has shown to be safe, and to improve renal function and graft structural integrity after induced warm ischemic damage. The next step is to introduce the Airdrive™ system in a clinical setting. To this end, a pilot-study using the Airdrive™ system for the preservation of kidney grafts was devised to demonstrate that the machine perfusion system is ‘safe’ for use in the clinical setting. In this pilot-study we hypothesize that the use of the Airdrive™ machine perfusion system is safe and technically feasible for graft preservation in kidney transplantation.
- Main changes (audit trail)
- RECORD4-mei-2016 - 1-jul-2016

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