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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2021-03-24

Brief Summary

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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.

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Detailed Description

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Platelets are currently stored in liquid form for a maximum of five to seven days. To extend the shelf-life of platelets, DMSO is added to freeze platelets for long-term storage. In vitro studies have shown that such cryopreserved platelets can be kept for at least two years at -80oC. This study is a clinical trial that aims to primarily assess the safety of cryopreserved pooled buffy coat-derived platelets in patients with hypoproliferative thrombocytopenia and no platelet refractoriness.

Subjects will be randomised into two arms either a liquid platelet (control) or frozen platelet arm (treatment) and may receive four or more platelet transfusions per thrombocytopenic cycle. Each subject may participate in the study for up to two thrombocytopenic period, assuming a wash-out period of at least five days (during which the subject receives no platelet transfusions) between the two thrombocytopenic periods. If subjects participate in the study for more than one thrombocytopenic period, they will automatically be enrolled in the opposing arm for their second thrombocytopenic period.

Conditions

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Hypoproliferative Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a phase 1b/2a single centre clinical trial. Eligible hypoproliferative thrombocytopenic adult patients enrolled in the study will be randomised into two arms. One arm is the "treatment" arm using cryopreserved platelets and the second is the "control" arm using liquid platelets. A recruitment period of two years is expected for 17 subjects in each arm. Subjects will automatically be crossed over to the other treatment arm once they have completed the first treatment arm and there is at least a 5-days interval without platelet transfusion. Subjects can be both inpatient and outpatient. During the thrombocytopenic period of 28 days, subjects may be required to have multiple platelet transfusions during this period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

Subjects in the "control" arm will receive normal pooled platelets for all of their transfusion within a single thrombocytopenic period. If subjects participate in the study for more than one thrombocytopenic period, they will automatically be enrolled in the opposing arm for their second thrombocytopenic period.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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

Treatment arm

Subjects in the "treatment" arm will receive thawed cryopreserved pooled platelets for all of their transfusions (except for unplanned or urgent platelet transfusions outside stipulated periods when thawed cryopreserved platelets are unavailable) within a single thrombocytopenic period. If subjects participate in the study for more than one thrombocytopenic period, they will automatically be enrolled in the opposing arm for their second thrombocytopenic period.

Group Type EXPERIMENTAL

Treatment arm receiving cryopreserved platelets

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Treatment arm receiving cryopreserved platelets

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. ≥ 21 years of age
2. Be able to provide written informed consent
3. 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
4. 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.
5. 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

2. Pregnant
3. Breastfeeding
4. Current platelet refractoriness
5. History of allergy or adverse reaction to DMSO
6. History of veno-occlusive disease
7. History of acute venous or arterial thromboembolism within the last 3 months.
8. History of unprovoked venous thromboembolism
9. On antiplatelets, NSAIDs or anticoagulants within 1 week, and TCM (traditional Chinese medicine) which are known to decrease platelet count or platelet function or increase bleeding tendency within 2 weeks of study enrolment.
10. Received or will be receiving L-asparaginase chemotherapy within 7 days of platelet transfusion
11. Renal impairment with calculated creatinine clearance of \<30ml/min.
12. Non-cutaneous Grade 2 and above bleeding at the time of study assessment
13. Presently with or a history of acute promyelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), haemolytic-uremic syndrome (HUS), or any thrombotic microangiopathy (TMA)
14. Presently with or a history of heparin-induced thrombocytopenia
15. Presently with disseminated intravascular coagulation (DIC) or other risk factor(s) for bleeding other than thrombocytopenia (including platelet dysfunction, PT ≥ 1.3 X upper limit of normal for the laboratory, PTT ≥ 1.3 X upper limit of normal for the laboratory, or fibrinogen ≤ 1 g/L)
16. History of anaphylaxis from blood transfusion
17. Involved in any other therapeutic clinical trials in the last 6 months prior to the start of this research
18. Concomitant participation in other therapeutic clinical trials during the full period of this study
19. Receiving non-trial-related medication that might compromise transfusion safety
20. Known history of congenital bleeding disorder
21. Subject who declined to consent for platelet transfusion

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No