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.
ID
Bron
Verkorte titel
Aandoening
Bleeding Grade 2-4
transfusion
pathogen reduction
thrombocytes
Ondersteuning
Sanquin Blood supply
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
WHO grade ≥ 2 bleeding complications of PCs.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Prior to, and 1 hr and 24 hr after PC-transfusion.
Onderzoeksproduct en/of interventie
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.
Publiek
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Wetenschappelijk
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1989 |
| NTR-old | NTR2106 |
| Ander register | - : ABR30643 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |