A randomised controlled trial of prophylactic versus no prophylactic platelet transfusions in patients with haematological malignancies

Not Applicable

Completed

• Conditions: Haematological malignancies; Blood - Haematological diseases; Cancer - Other cancer types

• Registration Number: ACTRN12609001087246
• Lead Sponsor: ational Health Service Blood & Transplant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients are eligible for this trial if:
1. They are aged 16 years or over
2. They have a confirmed diagnosis of a haematological malignancy
3. They have received or are going to receive myelosuppressive chemotherapy on this hospital admission with or without haematopoietic stem cell support (this includes patients undergoing haematopoietic stem cell transplantation - autologous or allogeneic)
4. They are thrombocytopenic or expected to become thrombocytopenic with a platelet count of less than 50 x 10e9/L for at least 5 days
5. They are able to comply with treatment and monitoring

Exclusion Criteria

Patients are not eligible for this trial if:
1. They have had a WHO Grade 3 or 4 bleed during any stage of their treatment to date
2. During the current admission, they have experienced or are currently experiencing a WHO Grade 2 or greater bleed
3. They have any inherited clotting disorder (e.g. haemophilia)
4. They need to remain on regular aspirin (or related drugs), or will require therapeutic doses of anticoagulants (e.g. heparin), during the whole period of thrombocytopenia
5. They have acute promyelocytic leukaemia and undergoing induction chemotherapy
6. They have known human leukocyte antigen (HLA) antibodies
7. They are pregnant
8. They have previously been randomised in this trial at any stage of their treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: The proportion of patients who experience (modified) WHO Grade 2, 3 or 4 bleeding event. The percentage of patients who experience a WHO Grade 2, 3, or 4 bleed by day 30 will be calculated for each arm.[30 days after randomisation]

Secondary Outcome Measures

Name	Time	Method
ogistic regression for proportion developing WHO Grade 3 or 4 bleed.[30 days after randomisation.];Cox proportional hazards regression model for time from randomisation to first WHO Grade 2, 3 or 4 bleed.[30 days after randomisation];Rate of bleeding events, as a fraction of the number of days with bleeding events divided by total number of days at risk of bleeding (the period of observation with thrombocytopenia).[30 days after randomisation.];Time from randomisation to second grade two bleed.[30 days after randomisation.];Period in hospital.[30 days after randomisation.];Total number of platelet transfusion episodes.[30 days after randomisation.];Total number of red cell transfusions.[30 days after randomisation.]