Study on the Safety and Efficacy of Cryopreserved Platelets in Hypoproliferative Thrombocytopenic… (NCT05067608) | Clinical Trial Compass
CompletedPhase 1/2
Study on the Safety and Efficacy of Cryopreserved Platelets in Hypoproliferative Thrombocytopenic Patients
Singapore17 participantsStarted 2019-10-25
Plain-language 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.
Who can participate
Age range21 Years – 99 Years
SexALL
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Inclusion criteria
✓. ≥ 21 years of age
✓. Be able to provide written informed consent
✓. Current or potential hypoproliferative thrombocytopenia with expected platelet count of \<20 X 109/L for a minimum of 5 days in a 28-day period
✓. If pre-menopausal female of child bearing potential, then the subject must have a negative serum pregnancy test prior to study commencement, and must be using an acceptable method of contraception during the study.
✓. Calculated creatinine clearance of \>30 ml/min (as calculated based on the Cockcroft-Gault equation; National Kidney Foundation 2017) at the point of recruitment, and within one week before transfusion
Exclusion criteria
✕. Not meeting the inclusion criteria specified above
✕. Pregnant
✕. Breastfeeding
✕. Current platelet refractoriness
What they're measuring
1
Incidence of adverse events related to platelet transfusion.
Timeframe: Monitoring will be for 24 hours (serum test 18-30 hours) post-transfusion.
2
Non-cutaneous Grade 2 or higher bleeding (as defined on the WHO bleeding scale)
Timeframe: Each thrombocytopenic period is up to 28 days from the first prophylactic platelet transfusion (shorter if platelet count recovers above target level before 28 days)