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Study on the Safety and Efficacy of Cryopreserved Platelets in Hypoproliferative Thrombocytopenic Patients

NCT05067608 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-05

No results posted yet for this study

Summary

The purpose of this study is to study the safety and efficacy of pooled buffy-coat derived platelets which had been frozen with dimethyl sulphoxide (DMSO), in the prevention of bleeding for patients with hypoproliferaitve thrombocytopenia. These platelets are hereafter referred to as cryopreserved platelets. Patients who have severely low platelet count due to impaired bone marrow function from chemotherapy or certain haematological conditions may need platelet transfusion to prevent spontaneous bleeding. Currently, platelets are stored in liquid form, and must be used within five to seven days of collection. In this study, DMSO is used to preserve platelets during freezing so that they can be stored for longer than five to seven days. Investigators hope to learn if thawed cryopreserved platelets are functional and safe for transfusion in humans.

Conditions

  • Hypoproliferative Thrombocytopenia

Interventions

BIOLOGICAL

Control arm receiving normal (never before frozen) platelets as per current clinical practice

Liquid platelets arm (control) and may receive multiple platelet transfusions per thrombocytopenic cycle.

BIOLOGICAL

Treatment arm receiving cryopreserved platelets

Cryopreserved platelets arm (treatment) and may receive multiple platelet transfusions per thrombocytopenic cycle.

Sponsors & Collaborators

  • DSO National Laboratories

    collaborator OTHER

  • Health Sciences Authority, Singapore

    collaborator UNKNOWN

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Ang Ai Leen · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2021-03-24
Completion
2021-03-24

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067608 on ClinicalTrials.gov