Platelet Cryopreservation

NCT07235436 | Completed

• 1 other identifier: 1221/2020/TESS/IRCCSRE
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet Cryopreservation

Keywords

onco-hematological patient; cryopreservation; transfusion; platelets

Outcome Measures

Primary Outcomes (4)

• Platelet Recovery Rate After Cryopreservation (Percentage of Initial Count)

  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)

  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

  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

  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 Outcomes (5)

• Release of Pro-Inflammatory Cytokines After Cryopreservation (Concentration in pg/mL)

  through study completion, an average of 4 year

• Morphological Integrity of Platelets After Cryopreservation (Percentage of Normal Platelets)

  through study completion, an average of 4 year

• Hemostatic Potential by Thromboelastography - Clotting Time

  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)

  through study completion, an average of 4 year

• Hemostatic Potential by Thromboelastography - Maximum Clot Firmness

  through study completion, an average of 4 years.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Platelet donors

You may qualify if:

• Written informed consent

You may not qualify if:

• refusal or inability to provide written informed consent

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (9)

• Ang AL, Gan LSH, Tuy TT, Ang CH, Tan CW, Tan HH, Shu PH, Zhang Q, Cao Y, Moorakonda RB, Pokharkar Y, Lu J. A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients. Transfusion. 2023 Sep;63(9):1649-1660. doi: 10.1111/trf.17503. Epub 2023 Aug 19.

  PMID: 37596937 BACKGROUND

• Christodoulides A, Zeng Z, Alves NJ. In-vitro thromboelastographic characterization of reconstituted whole blood utilizing cryopreserved platelets. Blood Coagul Fibrinolysis. 2021 Dec 1;32(8):556-563. doi: 10.1097/MBC.0000000000001075.

  PMID: 34475333 BACKGROUND

• Jimenez-Marco T, Castrillo A, Hierro-Riu F, Vicente V, Rivera J. Frozen and cold-stored platelets: reconsidered platelet products. Platelets. 2022 Jan 2;33(1):27-34. doi: 10.1080/09537104.2021.1967917. Epub 2021 Aug 22.

  PMID: 34423718 BACKGROUND

• Reade MC, Marks DC, Howe B, McGuinness S, Parke R, Navarra L, Charlewood R, Johnson L, McQuilten Z; CLIP-II and CLIPNZ-II Investigators.; CLIP-II and CLIPNZ-II Investigators. Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials). BMJ Open. 2022 Dec 20;12(12):e068933. doi: 10.1136/bmjopen-2022-068933.

  PMID: 36600425 BACKGROUND

• Johnson L, Tan S, Wood B, Davis A, Marks DC. Refrigeration and cryopreservation of platelets differentially affect platelet metabolism and function: a comparison with conventional platelet storage conditions. Transfusion. 2016 Jul;56(7):1807-18. doi: 10.1111/trf.13630. Epub 2016 May 9.

  PMID: 27158813 BACKGROUND

• Johnson L, Reade MC, Hyland RA, Tan S, Marks DC. In vitro comparison of cryopreserved and liquid platelets: potential clinical implications. Transfusion. 2015 Apr;55(4):838-47. doi: 10.1111/trf.12915. Epub 2014 Nov 5.

  PMID: 25371169 BACKGROUND

• Johnson L, Tan S, Jenkins E, Wood B, Marks DC. Characterization of biologic response modifiers in the supernatant of conventional, refrigerated, and cryopreserved platelets. Transfusion. 2018 Apr;58(4):927-937. doi: 10.1111/trf.14475. Epub 2018 Jan 12.

  PMID: 29330877 BACKGROUND

• Slichter SJ, Jones M, Ransom J, Gettinger I, Jones MK, Christoffel T, Pellham E, Bailey SL, Corson J, Bolgiano D. Review of in vivo studies of dimethyl sulfoxide cryopreserved platelets. Transfus Med Rev. 2014 Oct;28(4):212-25. doi: 10.1016/j.tmrv.2014.09.001. Epub 2014 Sep 21.

  PMID: 25439164 BACKGROUND

• Gavioli G, Razzoli A, Bedolla DE, Di Bartolomeo E, Quartieri E, Iotti B, Berni P, Birarda G, Vaccari L, Schiroli D, Marraccini C, Baricchi R, Merolle L. Cryopreservation affects platelet macromolecular composition over time after thawing and differently impacts on cancer cells behavior in vitro. Platelets. 2023 Dec;34(1):2281943. doi: 10.1080/09537104.2023.2281943. Epub 2023 Nov 27.

  PMID: 38010129 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 19, 2025
• Study Start: December 31, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

IT (1)