HOVON HO82

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Main info

Identificatie:
HOVON 82 Sanquin
Sponsor:
HOVON
Included patients:
295
Active sites:
8
(of 8)
Title:

Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients.

Timeline

Scheduled
Actual
2007
01 feb.
Activated
2020
24 okt.
Archived

News

Closure of the HOVON 82 Triplate study

Recently, inclusion in the HOVON 82 study has been stopped after reaching the target number of patients. Earlier, the PRPAS3 (Intercept) arm was closed following the recommendations of the Study Safety Committee. There were no major safety issues, warranting preliminary publication. The final results of the study will be analyzed and presented later this year.

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:
  • Determination of non-inferiority of PR platelet concentrates

(PR-PAS III-PC) and platelet concentrates in additive solution (PAS III-PC) compared to plasma (plasma-PC), stored for 1-7 days, in terms of recovery, estimated by mean corrected count increment (CCI) at 1 hour.

  • To assess the effectiveness in relation to storage time of the used platelet product.
  • To evaluate whether clinical factors interact with the different study products leading to a difference in platelet refractoriness.
  • To assess the 24 hour CCI.
  • To assess the safety (bleeding complications and adverse transfusion reactions).
  • To assess the transfusion requirement (red cells and platelets).
  • To assess the transfusion interval.

Eligibility

Inclusion Criteria:
  • Age >= 18 years.
  • Expected >= 2 platelet transfusion requirements.
  • Written informed consent.
  • Having a hemato-oncological disease.
Exclusion Criteria:
  • Known immunological refractoriness to platelet transfusions, i.e. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies.
  • Pregnancy (or lactating)
  • Previous inclusion in this study

Participating Sites

Site
8 results
Order by
Accrual rate
Activation date
NL-Den Haag-HAGA
81
NL-Rotterdam-ERASMUSMC
71
NL-Nijmegen-RADBOUDUMC
42
NL-Leiden-LUMC
39
NL-Rotterdam-EMCDANIEL
31
NL-Maastricht-MUMC
20
NL-Amsterdam-VUMC
8
NL-Amsterdam-AMC
3
= Active hospitals
= Inactive hospitals

Participating Parties

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