ATTACH

Study Title

Analysis of Thrombocyte Transfusion in Cardiothoracic surgery and Hematology program
The ATTACH program contains:
Part I: Safety
Part II: Efficacy in cardiothoracic (A) and hemato-oncologic patients (B)
Part III: Cost effectiveness in cardiothoracic (A) and hemato-oncologic patients (B)

Background 

Platelet transfusions are used to prevent and treat bleeding in patients with thrombocytopenia or thrombocytopathy. In recent decennia, plasma reducing strategies for platelet products have been developed, such as PAS (platelet additive solution) in order to reduce adverse transfusion reaction, to reduce the levels of anti-A and –B antibodies and to increase the availability of plasma for other purposes. Currently, both PAS and plasma-stored platelets are used. Studies in relatively small and select patient populations suggest that platelets stored in PAS induce fewer side effects than plasma-stored platelets. However, the clinical efficacy of PAS compared to plasma-stored platelets seems to be decreased as well, but the literature about this subject is limited.
These studies did not examine whether PAS-stored platelets also reduce the risk of adverse reactions in routine clinical practice in non-selected patient populations. In part I of this program we will compare the incidence of adverse transfusion reactions (ATRs) of PAS-stored platelets and plasma-stored platelets. Because platelets are mostly transfused to cardiac surgery and hemato-oncology patients, we will assess the efficacy of platelet transfusion in these specific patient categories in part II of this program. Finally, both safety and efficacy parameters will be used to develop models for a cost-effective analysis in part III of this study.

Objectives

To monitor current and possibly also new products in a systematic and continuous way.
To assess the occurrence of ATRs of plasma-reduced platelet concentrates compared to plasma-stored platelets in non-selected patients. In addition we will determine the clinical efficacy and cost-effectiveness of both products in cardiothoracic surgery and hematology patients.

Study design

The ATTACH study is an observational study in 22 Dutch hospitals. Please, find the study protocol below.

Attach version 2 (pdf)

 

Study population 

All patients receiving platelet transfusions between January 2012 and January 2016 in the participating hospitals.

Main study parameters/endpoints

The endpoints in this study are transfusion reactions (including bacteraemia), thrombosis, count increments and haemostatic efficacy.

Research staff 

• FMA van Hout MD^1,4
• AL Kreuger MD^1,4
• O Zouitni Msc²
• Prof JG van der Bom MD PhD^3,4
• RA Middelburg MD, PhD^3,4
• JL Kerkhoffs MD PhD^3,5

Collaborators

• Prof JJ Zwaginga MD PhD⁶
• MP Janssen, PhD⁷
• WL de Kort, PhD⁸
• M Palmen, MD PhD⁹
• Klautz MD PhD⁹

1. Principal investigator, PhD student, Center for Clinical Transfusion Research, Sanquin, Leiden, The Netherlands
2. Data manager, Center for Clinical Transfusion Research, Sanquin, Leiden, The Netherlands
3. Project leader, Center for Clinical Transfusion Research, Sanquin, Leiden, The Netherlands
4. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
5. Internist-haematologist Haga ziekenhuis 
6. Blood Transfusion Medicine, LUMC, Leiden
7. Researcher Medical Technology Asessment Sanquin, UMC Utrecht
8. Head Donor Studies Sanquin Research
9. Cardio-thoracic surgeon LUMC