A pilot multicentre blinded randomised controlled clinical trial of frozen platelets vs. conventional liquid-stored platelets for the management of post-surgical bleeding

Phase 2

Recruiting

• Conditions: Thrombocytopenia; Haemorrhage; Blood - Clotting disorders; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12612001261808
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Aged 18 years or older
2. Undergoing cardiac surgery with anticipated post-operative management in an ICU
3. Presence of an arterial line, central line and continuous monitoring for the purposes of surgery and postoperative care
4. Written informed consent obtained prior to surgery
5. Patients with any three of the following 28:
a. Preoperative haemoglobin < 13.5 g/dL
b. Female sex
c. Redo surgery
d. Preoperative creatinine >120 umol/L
e. Non-elective surgery
f. Age > 65
g. Body weight < 77kg (estimated or actual)
h. Non-isolated surgery

Exclusion Criteria

1. Receipt of platelet transfusion during this hospital admission
2. Women of child bearing age (18-55 years)
3. Death is deemed imminent and inevitable in <24hrs
4. Previous enrolment in this study
5. Previous enrolment in a clinical trial of a medication or technique thought to influence bleeding during this admission, with the exception of any trial of aspirin.
6. Known bleeding diathesis (for example, hemophilia or Von Willebrand Disease) or haematological malignancy, associated with abnormal clotting indices on blood investigations taken in the immediate preoperative period (i.e. platelet count <100 000, INR>1.5, aPTT > 1.5 x upper limit of normal)
7. Known allergy to dimethylsulphoxide (DMSO)
8. Known objection to receipt of human blood products
9. Intellectual impairment
10. The treating physician believes it is not in the best interest of the patient to be randomised in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protocol feasability, as assessed by:<br>- anticipated number and proportion of patients enrolled <br>- intervention delivered as per protocol, and <br>- outcome measures able to be assessed[1 year from first randomisation];Acceptability to clincians in comparison to conventional platelet transfusion, as assessed by:<br>- willingness to enrol patients into the study (inferred from recruitment rate and proportion of eligible patients)<br>- willingness to continue with study treatments rather than switch to open-label platelets (inferred from number of protocol violations)[1 year from first randomisation]