No registrations found.
ID
Source
Brief title
Health condition
Bleeding Grade 2-4
transfusion
pathogen reduction
thrombocytes
Sponsors and support
Sanquin Blood supply
Intervention
Outcome measures
Primary outcome
WHO grade ≥ 2 bleeding complications of PCs.
Secondary outcome
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.
Background summary
The study is a prospective, randomized multicenter trial for the evaluation of platelet products in hemato oncological patients with thrombocytopenia or expected to become thrombocytopenic caused by myelosuppressive therapy or malignancy-related myelosuppression. In this trial patients will be randomized to receive one of two platelet products during a transfusion episode with a maximum of 6 weeks.
Because the Mirasol-treated platelet products show a color difference not allowing an appropriate placebo, the study will be single-blinded for investigators evaluating the bleeding score.
Products will be stored up to 7 days. The primary endpoint is restricted to 5 days storage as this implies the most relevant information. Secondary endpoint evaluation requires that the patient continues treatment in the assigned study arm.
Arm A: Plasma stored platelet concentrates (Plasma-PCs);
Arm B: Pathogen reduced plasma-stored platelet concentrates (PR-plasma-PCs).
20-01-2013: In accordance with the METC, some changes have been accepted:
WHO bleeding scale is used to allow comparison with other trials in the area of platelet transfusion.
Study objective
Non-inferiority (defined as < 12.5% increase) of pooled buffy coat-derived PR platelet concentrates (PR-plasma-PCs) compared to plasma (plasma-PCs) in terms of clinical efficacy determined by WHO grade ≥ 2 bleeding complications.
Study design
Prior to, and 1 hr and 24 hr after PC-transfusion.
Intervention
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.
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1989 |
| NTR-old | NTR2106 |
| Other | - : ABR30643 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |