STUDY OF SURVIVAL AND FUNCTIONALITY IN CRYOPRESERVED PLATELETS

NCT04754841 | Unknown DMC

• 1 other identifier: 1021
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 2

Brief Summary

Platelets correspond to one of the most widely used blood components in transfusion medicine, given their importance in the prevention of bleeding disorders in patients with multifactorial thrombocytopenia and non-immunological etiology, as well as in the management of traumatic or blood-related bleeding. surgical treatments. Given its wide margin of use and the constant demand for it for use within the different management schemes and procedures associated with the medical act, it is the objective of both hemotherapy services and blood banks and blood products to have availability component constant to meet such requirements. The main problem of this resource is its short useful life (5 to 7 days) which limits its availability, especially in the Latin American context where the production of blood components as well as the resources allocated for this purpose by state entities to blood banks are generally limited. Cryopreservation at -80 ° C using Dimethylsulfoxide as a preservative solution is a technique used since the 1950s to prolong platelet survival, the improvement of which has been remarkable in recent years, thus constituting an alternative for the resolution of this problem.

Conditions

Platelet Cryopreservation; Platelet Survival

Keywords

SURVIVAL; FUNCTIONALITY; CRYOPRESERVED PLATELETS; IN VITRO

Outcome Measures

Primary Outcomes (1)

• survival of cryopreserved platelets greater than 28 days

  Between 1 and 3 months

Secondary Outcomes (1)

• viability of cryopreserved platelets greater than 50%

  Between 1 and 3 months

Study Arms (1)

SURVIVAL AND FUNCTIONALITY INVITRO IN CRYOPRESERVED PLATELETS

EXPERIMENTAL

Platelet concentrates will be administered 3 alternatives of cryopreservative solution: 5% dimethylsulfoxide (solution 1), 5% dimethylsulfoxide plus 160 mg of 5% dextrose (solution 2) and 5% dimethylsulfoxide plus 2% albumine (solution 3 ). They will then be frozen at -80 ° C and their survival and functionality will be subsequently evaluated in vitro.

Other: platelet cryopreservation

Interventions

platelet cryopreservation OTHER

The cryopreservation of platelets will be carried out using as alternatives of cryopreservative solution: 5% dimethylsulfoxide alone (solution 1) or combined with 5% dextrose 160 mg (solution 2) or with 2% albumin (solution 3) and then be frozen at -80 ° C

SURVIVAL AND FUNCTIONALITY INVITRO IN CRYOPRESERVED PLATELETS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concentrates from donors over 18 years of age who meet the requirements established by law 22990 for donating blood and blood components will be included in this study, from whom a number of platelets greater than or equal to 3 x10 E11 can be collected

You may not qualify if:

• Platelet concentrates that present any of the following characteristics will be excluded from the investigation:
• Concentrates that have not met all of the standards required for use in humans or that at the time of the study more than 24 hours have passed since they were obtained.

Sponsors & Collaborators

• HOSPITAL BRITANICO DE BUENOS AIRES: lead

Study Sites (2)

Hospital Britanico Buenos Aires

Buenos Aires, 1082, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

Buenos Aires, 1406, Argentina

COMPLETED

Related Publications (4)

• Johnson L, Cameron M, Waters L, Padula MP, Marks DC. The impact of refrigerated storage of UVC pathogen inactivated platelet concentrates on in vitro platelet quality parameters. Vox Sang. 2019 Jan;114(1):47-56. doi: 10.1111/vox.12730. Epub 2018 Nov 30.

  PMID: 30499111 BACKGROUND

• 7. Bohonek, Milos;Cryopreservation of Platelets: Advances and Current Practice; Cryopreservation Biotechnology in Biomedical Sciences ;2018;Chapter4;P47-66

  RESULT

• Waters L, Cameron M, Padula MP, Marks DC, Johnson L. Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions. Vox Sang. 2018 May;113(4):317-328. doi: 10.1111/vox.12640. Epub 2018 Feb 14.

  PMID: 29441601 RESULT

• Eker I, Yilmaz S, Cetinkaya RA, Pekel A, Unlu A, Gursel O, Yilmaz S, Avcu F, Musabak U, Pekoglu A, Ertas Z, Acikel C, Zeybek N, Kurekci AE, Avci IY. Generation of Platelet Microparticles after Cryopreservation of Apheresis Platelet Concentrates Contributes to Hemostatic Activity. Turk J Haematol. 2017 Mar 1;34(1):64-71. doi: 10.4274/tjh.2016.0049. Epub 2016 Apr 18.

  PMID: 27094612 RESULT

Study Officials

• GLENDA ERNST

  HOSPITAL BRITANICO DE BUENOS AIRES

  STUDY CHAIR

• JHON AVILA

  HOSPITAL BRITANICO DE BUENOS AIRES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JHON AVILA

CONTACT

+5491141879723; jaavilar@gmail.com

JOSE ACOSTA

CONTACT

jacosta@fundaleu.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Cryopreserved samples will be labeled with a code unknown to the researcher and those who process the sample in the laboratory.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Internal Medicine an Hematology

Model Details: A blind experimental study will be carried out (those who evaluate viability and functionality of platelets will not know the cryopreservation times or the concentration of the cryopreservative) Aliquots of platelets with group and factor A +, A-, B +, B-, AB +, AB-, O + and O- obtained from those people who come to the hemotherapy center as voluntary donors and who in turn express their decision to participate in this protocol by signing an informed consent designed for this purpose.

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 15, 2021
• Study Start: February 3, 2021
• Primary Completion: August 28, 2021
• Study Completion: February 2, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)