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MORE DATa study


- candidate number29291
- NTR NumberNTR7406
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2018
- Secondary IDsNL 60718.099.18 ABR nummer
- Public TitleMORE DATa study
- Scientific TitleMOnocyte REsponse after acute DAmage of Tissue - a proof of concept study
- ACRONYMMORE DATa
- hypothesisThe existence of a “monocyte left-shift” after (severe) tissue damaga.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Immune respons, Knee arthroscopy, Monocyte populations
- Inclusion criteria- elective knee arthroscopy or an elective total hip arthroplasty (posterolateral approach) for primary osteoarthritis
- between 18 and 70 years of age
- signed informed consent
- Exclusion criteria- pre-existing immune deficiency
- use of immunosuppressant drugs
- orthopaedic surgery in the last two years
- cognitive impairments
- Evident infectious complications such as pneumonia, surgical site infection (SSI) and/or urinary tract infection (UTI), during postoperative course
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2018
- planned closingdate1-aug-2019
- Target number of participants12
- Interventions5mL of peripheral blood will be drawn preoperatively and postoperatively, with a small margin, at 2 hr, 6 hr, 24 hr, 36 hr, 48 hr and 1 week. After blood samples have been obtained from the patients, the material will be transported at 4⁰C to the LUMC laboratory site for analysis.
- Primary outcomeExpression of early and late markers that identify the maturation stage of monocyte subpopulations.
- Secondary outcome- Absolute numbers of monocyte subpopulations and lymphocyte populations.
- Serum interleukines and classical tissue damage marker (CRP and CK) levels.
- Timepoints5mL of peripheral blood will be drawn preoperatively and postoperatively, with a small margin, at 2 hr, 6 hr, 24 hr, 36 hr, 48 hr and 1 week.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.J. Vries, de
- CONTACT for SCIENTIFIC QUERIESDrs. A.J. Vries, de
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryInformation on the extent of tissue damage after trauma, surgery, disease or therapy is an important paramter in the clinical evaluation of patients and can prevent complications. Unfortunately currently no reliable minimal invasive methods exist to examine such tissue damage. New insights in the kinetics of blood leukocytes after surgical procedures have shown that monitoring of tissue damage can be performed via small amounts of peripheral blood – the monocyte subpopulations change remarkebly in the early phase after surgery. Patients after total hip replacement demonstrated a massive increase of classical monocytes after a notable decrease, 24 hours after surgery. A possible explanation for this phenomenon could be massive recruitment from the bone marrow after large numbers of blood monocytes have migrated into the tissue. This bone marrow recruitment would then resemble the granulocytic left-shift that can be found during or after acute infections. If this hypothesis is correct, a large proportion of the classical monocytes should have a more ‘immature’ phenotype.
This study will evaluate the monocyte phenotype at several time points after a total hip replacement surgery (severe tissue damage) and a knee arthroscopy (minimal tissue damage).
- Main changes (audit trail)
- RECORD18-jul-2018 - 10-aug-2018


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