Clinical trial NCT02894671: Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Official title: Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group Identification
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females

Brief summary: The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. The opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.

Detailed description: 100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the Medical technology laboratory for IMA dosage. In addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. The investigators will be able to analyze the IMA and normalized IMA distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).

Eligibility criteria: * Inclusion Criteria:
* caucasic
* signed informative consensus
* Exclusion Criteria:
* patients wearing articular devices
* pregnant (for female)
* fractured patients
* patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (Hb\<9)

Primary outcomes:
measure: IMA dosage
timeFrame: one year
Secondary outcomes:
measure: iron, transferrin dosages
timeFrame: one year
measure: Ferritin dosages
timeFrame: one year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Giovanni Bracci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Govender R, De Greef J, Delport R, Becker PJ, Vermaak WJ. Biological variation of ischaemia-modified albumin in healthy subjects. Cardiovasc J Afr. 2008 May-Jun;19(3):141-4.
citation: Catalani S, Leone R, Rizzetti MC, Padovani A, Apostoli P. The role of albumin in human toxicology of cobalt: contribution from a clinical case. ISRN Hematol. 2011;2011:690620. doi: 10.5402/2011/690620. Epub 2010 Oct 31.
citation: Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, Winkler JV, Yukl RL, Kingston RG, Curtis CG. An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochem Biophys Res Commun. 2001 Jun 15;284(3):856-62. doi: 10.1006/bbrc.2001.5042.