The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score.

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato oncological patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21216

Enrollment

618

Registered

2009-11-13

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Bleeding Grade 2-4 transfusion pathogen reduction thrombocytes

Interventions

1. Pooled buffy coat-derived pathogen reduced platelet concentrates (PR-plasma-PCs), or

2. Plasma (plasma-PCs), stored for 1-7 days. Time of intervention has a maximum of 6 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ≥ 18 years; 2. Expected ≥ 2 platelet transfusion requirements; 3. Signed informed consent; 4. Having hemato oncological disease including those who undergo myelo ablative allogeneic stem cell transplant therapy.

Exclusion criteria

Exclusion criteria: 1. Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP; 2. Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding); 3. Known immunological refractoriness to platelet transfusions; 4. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies; 5. Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO); 6. Pregnancy (or lactating); 7. Prior treatment with pathogen-reduced blood products; 8. Known allergy to riboflavin or its photoactive products.

Design outcomes

Primary

Measure	Time frame
WHO grade ≥ 2 bleeding complications of PCs.	—

Secondary

Measure	Time frame
Using PCs, stored for 1-7 days: 1. The 1 and 24 hour CI; 2. The 1 and 24 hour CCI; 3. (1+24 hour CCI)/2; 4. Adverse transfusion reactions; 5. Total transfusion requirement of red cells and platelets; 6. Platelet transfusion interval; 7. Rate of HLA allo-immunization; 8. In vitro quality markers related with the 1-hour or 24-hour CCI; 9. Clinical factors interacting on primary endpoint, including in vivo variables of immunological responses and of hemostasis in the recipients after transfusion as compared prior to transfusion.	—

Measure

Time frame

Using PCs, stored for 1-7 days: 1. The 1 and 24 hour CI; 2. The 1 and 24 hour CCI; 3. (1+24 hour CCI)/2; 4. Adverse transfusion reactions; 5. Total transfusion requirement of red cells and platelets; 6. Platelet transfusion interval; 7. Rate of HLA allo-immunization; 8. In vitro quality markers related with the 1-hour or 24-hour CCI; 9. Clinical factors interacting on primary endpoint, including in vivo variables of immunological responses and of hemostasis in the recipients after transfusion as compared prior to transfusion.

—

Contacts

Public ContactJ.L.H. Kerkhoffs

HagaHospital, Leyweg 275

J.Kerkhoffs@hagaziekenhuis.nl+31 (0)70 3592004

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)