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Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP)

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ClinicalTrials.gov Identifier: NCT01789762
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
Etablissement Français du Sang

Brief Summary:

This study is a multicentre, double-blind, randomized therapeutic trial.

The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage:

  • of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA procedure)
  • compared with the usual platelet concentrates (in additive solution intersol), reference arm, and
  • compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS).

The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.


Condition or disease Intervention/treatment Phase
Aplasia With Expected Thrombocytopenia Biological: Autologous plasma Biological: Additive solution Biological: Pathogen reduction process Phase 4

Detailed Description:

There is an unresolved difficulty in the evaluation of haemorrhagic symptoms in thrombocytopenia due to the very nature of the scale, which is the international standard at this time (WHO scale). This scale is based on the level of blood loss and is applicable to any haemostasis disorder. We will keep it as the standard but have decided to be particularly rigorous in the data collection and will perform daily haemorrhagic assessment.

Several sequences of missing data can be imputed for one patient. Each sequence of missing data will be replaced if and only if the number of consecutive days missing does not exceed 15%* of the total length of the patient's stay. If one sequence of missing data is longer than the 15%, no replacement will be done for the patient. (Example: If the total stay is 30 days, the maximal length of a missing data sequence accepted is 4 days). The following strategies will be used to replace missing data:

• The first observation is missing: Next observation carried backwards (NOCB) assigns the next known score after the missing value to the missing one.

• The last observation is missing: Last observation carried forward (LOCF) assigns the last known score before the missing value to the missing one. (Suppose that the situation is stable whilst the patient is leaving the hospital.)

• Sequence of one or several missing data with non-missing data before and after the sequence: Last and Next1 assigns the average of the person's last known and next known observation to the missing value. The score is rounded down to the nearest whole number if needed. (Ex mean (1+2) =1)

* 15% rounded up to nearest whole number.

1 : Engels, J.M. 2003. Imputation of Missing Longitudinal Data : a Comparison of Methods. Journal of Clinical Epidemiology 56 (2003) 968-976

Following a quality analysis of EFFIPAP study's recruitment, it was decided by the sponsor to increase the number of patients. Approximatively thirty additional patients will be included in order to replace non analyzable patients for the following reasons : wrongly included, non-transfused patients, consent withdrawal. Those 30 additional patients will allow us to reach our initial target of 810 analyzable patients in order to respond to the main objective of the study


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 842 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Active Comparator: Historical control arm
Patients transfused with platelet concentrates re-suspended in autologous plasma
Biological: Autologous plasma
Transfusions of platelet concentrates re-suspended in autologous plasma

Active Comparator: Control arm
Patients transfused with platelets prepared in additive solution
Biological: Additive solution
Transfusions of platelets prepared in additive solution (Intersol)

Experimental: Experimental arm
Patients transfused with platelets treated by pathogen reduction process
Biological: Pathogen reduction process
Patients transfused with platelets treated by pathogen reduction process




Primary Outcome Measures :
  1. Incidence of grade 2 or higher (WHO) haemorrhagic episodes [ Time Frame: During 1 month ]

Secondary Outcome Measures :
  1. Frequency incidence of haemorrhagic episodes (grade 1 and higher) [ Time Frame: During 1 month ]
  2. Number of serious grade 3-4 haemorrhagic episodes [ Time Frame: During 1 month ]
  3. Number of minor grade 1 haemorrhagic episodes [ Time Frame: During 1 month ]
  4. Transfusion outcome in platelets (CCI) at 24 hours [ Time Frame: During 1 month ]
  5. Number of transfusions of platelet concentrates and red blood cells [ Time Frame: During 1 month ]
  6. Transfusion intervals [ Time Frame: During 1 month ]
  7. Safety (transfusion side effects) grade 2 or higher [ Time Frame: During 1 month ]
  8. Occurrence of anti-platelet antibodies (Anti-HLA, anti-HPA) [ Time Frame: During 1 month ]
  9. Occurrence of platelet transfusions refractiveness [ Time Frame: During 1 month ]
  10. Validation of a new haemorrhagic evaluation: EFS scale [ Time Frame: During 1 month ]
  11. Variation in hematocrit and hemoglobin levels [ Time Frame: During 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years or older
  • Patient hospitalised for bone marrow aplasia, with expected stay of over 10 days and in principle requiring platelet transfusion support (at least twice).
  • Signed informed consent
  • Patients with DIC can be included; they will undergo a separate analysis.
  • A negative pregnancy test is necessary before inclusion in all women of childbearing age

Exclusion Criteria:

  • Patient included in this trial previously during a prior aplasia episode.
  • Patient requiring curative anticoagulant treatment at the time of inclusion (vitamin K antagonists, heparin (LMWH and NFH), anti-IIa and Xa at curative doses for treatment or prophylaxis of arterial or venous thromboembolic disease (TED) or as part of the treatment for cardiac valvulopathy and complications of atrial fibrillation).
  • Thrombocytopenia due to increased destruction
  • Patient requires washed platelet concentrates (i.e., with residual plasma less than that remaining during the addition of an additive solution) due to previous intolerance to platelets (cf IgA deficiency, history of major allergic reaction)
  • Patient requiring products "CMV negative " (previously included in a protocol transfusion CMV negative)
  • Patients with platelet transfusion refractoriness during a previous period of cytopenia, including patient with platelet refractoriness related to an anti-HLA alloimmunization (thus, patient already known as requiring compatible platelets HLA)
  • Patient who requires compatible HLA platelets due to a refractory state relative to anti-HLA alloimmunization
  • Patient presenting a platelet transfusion refractoriness at the time of previous aplasia.
  • Protected adults and persons deprived of liberty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789762


Locations
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France
CHU de Besancon
Besancon, France, 25030
CHU de Brest
Brest, France
CHU de Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Henri Mondor - APHP
Creteil, France, 94000
CHU de Dijon
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38700
Hopital Huriez - CHRU Lille
Lille, France, 59037
Institut Paoli Calmette
Marseille, France, 13273
Hopital Saint Antoine
Paris, France, 75012
Hospices Civils de Lyon - Lyon Sud
Pierre Benite, France, 69495
CHU de Rennes
Rennes, France, 35033
Institut de Cancérologie de la Loire
St Priest en Jarez, France, 42271
Sponsors and Collaborators
Etablissement Français du Sang
University Hospital, Grenoble

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Etablissement Français du Sang
ClinicalTrials.gov Identifier: NCT01789762     History of Changes
Other Study ID Numbers: 2012-P001
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Etablissement Français du Sang:
Platelet transfusions
Pathogen reduction
Haemorrhagic episodes
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Pharmaceutical Solutions