Critical care Other
Conditions
Interventions
Current interventions as of 10/06/2025:
T4P is a large-scale, multi-centre, data-enabled, registry-embedded, open-label, randomised, comparative effectiveness trial with an internal pilot across five
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 17/03/2023: 1. Adult (aged 18 years or older) 2. Accepted for admission or admitted to a participating critical care unit 3. Platelet count <50 x 10e9/l 4. Planned to undergo a specified* low bleeding risk invasive procedure OR platelet transfusion being considered for an 'other' procedure *Specified low bleeding risk invasive procedures include the following: 1. Central venous vascular catheter insertion (including vascular access for renal replacement therapy) 2. Paracentesis/superficial abdominal fluid collection drainage 3. Pleural aspiration ‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure and a platelet transfusion is being considered for the procedure. These include, but are not limited to, the following: 1. Arterial catheter insertion 2. Arterial or central venous catheter removal 3. Pleural drain 4. Interventional radiology (as defined by Society of Interventional Radiology guidelines) 5. Bronchoscopy with or without lavage 6. Wound dressing changes 7. Surgical procedures where the clinical team agree the risk of bleeding is low, e.g. re-look laparotomy, or wound closure Previous participant inclusion criteria: 1. Adult (aged 18 years or older) 2. Accepted for admission or admitted to a participating critical care unit 3. Platelet count <50 x 10e9/l 4. Platelet transfusion being considered for a low bleeding risk invasive procedure* *Low bleeding risk invasive procedures include the following: 1. Vascular catheter insertion and removal (central venous – including vascular access for renal replacement therapy) 2. Paracentesis/superficial abdominal fluid collection drainage 3. Pleural aspiration ‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure. These include, but are not limited to, the following: 1. Arterial catheter line insertion 2. Pleural drain 3. Interventional radiology (as defined by Society of Interventional Radiology guidelines) 4. Bronchoscopy with or without lavage 5. Wound dressing changes 6. Surgical procedures where the clinical team agree risk of bleeding is low, e.g. re-look laparotomy, or wound closure
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 17/03/2023: 1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention* 2. Intercranial haemorrhage within prior 72 hours* 3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects) 4. Acute promyelocytic leukaemia (APML) 5. Known advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses) 6. Death perceived as imminent or admission for palliation 7. Previously randomised into T4P 8. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours *Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for the trial Previous participant exclusion criteria: 1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention* 2. Intercranial haemorrhage within prior 72 hours* 3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects) 4. Advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses) 5. Death perceived as imminent or admission for palliation 6. Previously randomised into T4P 7. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours *Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 90 days measured through review of patient medical notes at 90 days post-randomisation and/or data linkage with nationally held death registrations. Primary health economic outcome measure: Incremental costs, quality-adjusted life year (QALYs) and net monetary benefit at 90 days, measured through combining Health-related Quality of Life (EuroQol EQ-5D-5L questionnaire) data, valued resource use data obtained via a health services questionnaire and data obtained through linkage with national hospital episode statistics, death registrations and the national clinical audit for adult critical care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at discharge from critical care unit, hospital and at 1 year, measured through review of patient medical notes at the relevant timepoints and/or data linkage with nationally held death registrations and the national clinical audit for adult critical care (for mortality at discharge) 2. Survival to longest available follow-up, measured by review of patient medical notes and/or data linkage with nationally held death registrations 3. Rates of major and fatal bleeds classified according to the HEmorhage Measurement (HEME) bleeding score, measured through review of patient medical notes up until critical care unit discharge 4. Venous and arterial thromboses in hospital and to 1 year, measured through review of patient medical notes at hospital discharge, data obtained via a health services questionnaire and through data linkage with national hospital episodes statistics and the NICE-mandated hospital-acquired venous thromboembolism (VTE) audit 5. Duration of renal, advanced cardiovascular and advanced respiratory support according to UK Critical Care Minimum Data Set (CCMDS) criteria, measured through review of patient medical notes during critical care admission and data obtained through linkage with the national clinical audit for adult critical care 6. Length of critical care unit and acute hospital stay, measured through review of patient medical notes and data obtained through linkage with the national clinical audit for adult critical care 7. Health-related quality of life measured through EQ-5D-5L questionnaire at 90 days and 1-year timepoints 8. Resource use and costs at 90 days and 1 year, measured by valuing resource use data obtained via a health services questionnaire administered to patients and through data linkage with national hospital episode statistics and the national clinical audit for adult critical care 9. Net monetary benefit (NMB) at 1 year, measured through combining health-related quality of life (EQ-5D-5L questionnaire) data, valu | — |
Countries
Australia, England, Ireland, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed