Platelet Cryopreservation (PLT-CRIO)

November 17, 2025 updated by: Azienda USL Reggio Emilia - IRCCS

Cryopreservation of Platelets for Prophylactic Use in Onco-haematology: an in Vitro Study

The study "Cryopreservation of Platelets for Prophylactic Use in Onco-Hematology: an in vitro Study", coordinated by Dr. Lucia Merolle at the Department of Transfusion Medicine of the Azienda USL-IRCCS of Reggio Emilia, aims to investigate the impact of cryopreservation methods on platelet functionality and metabolism. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The study design involves the recruitment of donors, preparation of platelet concentrates, and their cryopreservation. After thawing, the products undergo a series of biochemical and functional evaluations, including platelet count, pH measurement, pro-inflammatory cytokine levels, morphological assessment, and activity testing. Data will then be analyzed to determine the minimal effective concentration required for safe and effective use. Platelet apheresis samples are collected and analyzed. Participation is proposed to platelet donors at the Department of Transfusion Medicine, and inclusion requires the signing of written informed consent, while refusal to provide consent will exclude individuals from the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Platelets are essential blood components with pivotal roles in both hemostasis and inflammation. Thrombocytopenia, defined as a reduction in circulating platelet count, may result from impaired bone marrow production, increased consumption, splenic sequestration, or bleeding episodes, and is commonly managed through platelet transfusions aimed at restoring adequate counts and, when necessary, controlling hemorrhage. In clinical practice, the majority of platelet transfusions are administered to thrombocytopenic cancer patients with a prophylactic intent, where the primary requirement is sustained platelet survival to minimize the number of transfusions. Conversely, in actively bleeding patients, platelet transfusions are expected to provide rapid and efficient hemostasis, while their circulation time is of lesser relevance. Currently, platelet concentrates are stored at room temperature (22-24 °C) under continuous agitation for up to five days, after which they are discarded if unused. This storage method carries the risk of bacterial contamination and induces metabolic and structural changes that compromise platelet function, a phenomenon known as platelet storage lesion (PSL). Furthermore, the short shelf life limits the availability of platelets in emergency settings, as observed during the SARS-CoV-2 pandemic, when the demand for prophylactic platelet transfusions remained constant while supply was severely strained. In response, the Transfusion Medicine Unit in Reggio Emilia introduced cryopreservation of platelet concentrates to prevent future shortages. Cryopreservation allows storage of platelets for up to two years, offering an attractive alternative to conventional methods, not only extending storage duration but also reducing the risl of bacterial contamination. Although recent studies have demonstrated the safety and efficacy of cryopreserved platelets in bleeding patients, limited evidence exists for their use in prophylaxis among onco-hematologic patients. Major concerns include the potential for exacerbating thrombotic risk in patients with chronic hypercoagulability and the release of bioactive molecules such as growth factors and pro-inflammatory cytokines during thawing, which could have pro-tumorigenic effects. Platelet-tumor interactions are known to be complex, exerting both pro- and anti-tumoral influences, with the balance often favoring tumor progression. The present study therefore aims to evaluate the impact of cryopreservation on platelet functionality, structure and morphology, as well as to assess potential pro-tumoral effects after thawing. Using a comparative approach, cryopreserved platelets obtained by apheresis were analyzed alongside standard room-temperature stored platelets, currently considered the gold standard for prophylactic transfusion. The protocol involves donor recruitment at the Transfusion Medicine Unit of the AUSL-IRCCS of Reggio Emilia, with platelet concentrates prepared and cryopreserved using 6% dimethyl sulfoxide (DMSO) as well as alternative approaches employing intracellular and extracellular cryoprotectants, either individually or in combination, with lower cytotoxicity reported in other transfusion and cryobiology settings. Platelet samples were evaluated before freezing and after thawing at multiple time points (1, 3, and 6 hours post-reconstitution). Analyses included recovery rate, pH changes, release of bioactive factors, activation markers, hemostatic potential (via thromboelastography), and morphological alterations assessed by flow cytometry, microscopy, and synchrotron-based Fourier transform infrared (FTIR) microspectroscopy. Furthermore, the potential pro-tumoral activity of cryopreserved versus fresh platelets was investigated in vitro using co-culture systems with breast cancer and leukemia cell lines, focusing on proliferation, and platelet-cell interaction tests. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The secondary objective is to identify the cryopreserved platelet product with the most appropriate safety profile for prophylactic transfusion in onco-hematologic patients. The study is conducted by the BioMetLab at the Transfusion Medicine Unit of AUSL-IRCCS of Reggio Emilia in compliance with the Declaration of Helsinki, following informed consent from all donors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Azienda USL IRCCS di Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Platelet donors

Description

Inclusion Criteria:

  • Written informed consent

Exclusion Criteria:

  • refusal or inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Platelet Recovery Rate After Cryopreservation (Percentage of Initial Count)
Time Frame: through study completion, an average of 4 year
Platelet recovery will be assessed by calculating the percentage of platelets remaining after cryopreservation compared to pre-freezing values, expressed as recovery rate (%).
through study completion, an average of 4 year
Absolute Platelet Count After Cryopreservation (×10⁹/L)
Time Frame: through study completion, an average of 4 year
Platelet concentration will be determined using an automated hematology analyzer, expressed as absolute platelet count in ×10⁹/L.
through study completion, an average of 4 year
Platelet Function Assessed by Thromboelastography - Clot Formation Time
Time Frame: through study completion, an average of 4 year
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include clot formation time (in minutes) as a measure of platelet functional activity.
through study completion, an average of 4 year
Platelet Function Assessed by Thromboelastography - Maximum Amplitude
Time Frame: through study completion, an average of 4 years
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include maximum amplitude (in millimeters) as a measure of platelet functional activity.
through study completion, an average of 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Release of Pro-Inflammatory Cytokines After Cryopreservation (Concentration in pg/mL)
Time Frame: through study completion, an average of 4 year
Levels of IL-6 and TNF-α will be quantified in platelet supernatants using ELISA assays, expressed in pg/mL.
through study completion, an average of 4 year
Morphological Integrity of Platelets After Cryopreservation (Percentage of Normal Platelets)
Time Frame: through study completion, an average of 4 year
Morphology will be assessed by light microscopy and flow cytometry, expressed as the percentage of platelets retaining normal morphology.
through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Clotting Time
Time Frame: through study completion, an average of 4 year
Hemostatic potential will be evaluated with thromboelastography (TEG). The outcome includes clotting time (in minutes) as a measure of the hemostatic process.
through study completion, an average of 4 year
Pro-Tumoral Activity of Cryopreserved Platelets in Co-Culture with Cancer Cell Lines (Percentage Increase in Cell Proliferation)
Time Frame: through study completion, an average of 4 year
Platelet-tumor interaction will be assessed in vitro using breast cancer and leukemia cell lines. Results will be expressed as the percentage increase in cancer cell proliferation compared to controls.
through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Maximum Clot Firmness
Time Frame: through study completion, an average of 4 years.
Hemostatic potential will be evaluated with thromboelastography (TEG). The outcome includes maximum clot firmness (in millimeters) as a measure of clot stability.
through study completion, an average of 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1221/2020/TESS/IRCCSRE

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