Platelet Process Improvement Project

Comparison of platelets stored for 2 - 5 versus 6 - 7 days in preventing and treating haemorrhage in thrombocytopenic patients: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49080246

Enrollment

100

Registered

2008-03-26

Start date

2007-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia, haemorrhage Haematological Disorders Purpura and other haemorrhagic conditions

Interventions

Patients will be randomised to receive a sequence of transfusions in blocks of two, so that within each block there will be one allocation for standard 2 - 5 day old platelets, and one allocation for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (aged 16 or above) haemato-oncology patients who are thrombocytopenic because of bone marrow failure in Manchester Royal Infirmary and Bristol Royal Infirmary requiring platelet transfusion according to local and British Committee for Standards in Haematology (BCSH) guidelines.

Exclusion criteria

Exclusion criteria: 1. Inherited or acquired clotting disorders 2. Inherited or acquired platelet function disorders 3. Acute promyelocytic leukaemia 4. Previously documented World Health Organization (WHO) grade 4 bleeding (debilitating blood loss) 5. Pregnant females 6. Splenomegaly 7. Immunological refractoriness to platelet transfusion

Design outcomes

Primary

Measure	Time frame
The proportion of successful transfusions, of either 2 - 5 or 6 - 7 days, as measured by 18 - 24 hour Corrected Count Increment (CCI), within the first block. Platelet increment is defined as the post -transfusion platelet count minus pre-transfusion platelet count (x 10^9/L). The CCI is calculated from the platelet increment (PI), body surface area (BSA) in metres squared, and dose of platelets (PD) transfused (x 10^11). CCI = PI x BSA x PD-1 A successful transfusion is defined as a CCI greater than 4.5 x 10^9/L.	—

Measure

Time frame

The proportion of successful transfusions, of either 2 - 5 or 6 - 7 days, as measured by 18 - 24 hour Corrected Count Increment (CCI), within the first block. Platelet increment is defined as the post -transfusion platelet count minus pre-transfusion platelet count (x 10^9/L). The CCI is calculated from the platelet increment (PI), body surface area (BSA) in metres squared, and dose of platelets (PD) transfused (x 10^11). CCI = PI x BSA x PD-1 A successful transfusion is defined as a CCI greater than 4.5 x 10^9/L.

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Secondary

Measure	Time frame
1. Proportion of successful transfusions in all blocks 2. Mean 18 - 24 hour CCI following transfusions in the first block only 3. Mean 18 - 24 hour CCI following transfusions in all blocks 4. Proportion of days a patient has a bleeding score WHO grade 2 or more during the first and subsequent intervals between transfusions. Bleeding will be assessed and monitored daily using a structured assessment form. Assignment of bleeding grades to a modification of the WHO bleeding score will be performed by a computerised algorithm. 4. Interval (number of days) to the second and subsequent platelet transfusions 5. Incidence of acute reactions to each platlet transfusion	—

Measure

Time frame

1. Proportion of successful transfusions in all blocks 2. Mean 18 - 24 hour CCI following transfusions in the first block only 3. Mean 18 - 24 hour CCI following transfusions in all blocks 4. Proportion of days a patient has a bleeding score WHO grade 2 or more during the first and subsequent intervals between transfusions. Bleeding will be assessed and monitored daily using a structured assessment form. Assignment of bleeding grades to a modification of the WHO bleeding score will be performed by a computerised algorithm. 4. Interval (number of days) to the second and subsequent platelet transfusions 5. Incidence of acute reactions to each platlet transfusion

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026