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Human Fibrinogen Concentrate and Fresh Frozen Plasma in the Management of Severe Acquired Hypofibrinogenemia in Children With Acute Lymphoblastic Leukemia

Results of a Retrospective Survey

Giordano, Paola, MD*; Grassi, Massimo, MD; Saracco, Paola, MD; Luciani, Matteo, MD§; Colombini, Antonella, MD; Testi, Anna M., MD; Micalizzi, Concetta, MD#; Petruzziello, Fara, MD**; Putti, Maria C., MD††; Casale, Fiorina, MD‡‡; Consarino, Caterina, MD§§; Mura, Rosa M., MD∥∥; Mastrodicasa, Elena, MD¶¶; Notarangelo, Lucia D., MD##; Onofrillo, Daniela, MD***; Pollio, Berardino, MD; Rizzari, Carmelo, MD; Tafuri, Silvio, MD†††; De Leonardis, Francesco, MD; Corallo, Paola C., MD*; Santoro, Nicola, MD

Journal of Pediatric Hematology/Oncology: May 2019 - Volume 41 - Issue 4 - p 275–279
doi: 10.1097/MPH.0000000000001390
Original Articles

Objective of the Study: In this study we aimed to retrospectively evaluate how centers, belonging to the Associazione Italiana Ematologia e Oncologia Pediatrica (AIEOP), manage severe acquired hypofibrinogenemia in children with acute lymphoblastic leukemia, particularly evaluating the therapeutic role of human fibrinogen concentrate (HFC) and fresh frozen plasma (FFP).

Methods: We conducted a survey among AIEOP centers; thereafter, we collected and analyzed data with regard to the treatment of episodes of severe acquired hypofibrinogenemia occurring during the induction and reinduction phases of the AIEOP-BFM ALL 2009 protocol.

Results: In total, 15 of the 37 AIEOP centers invited to join the survey agreed to collect the data, with 10 and 5 centers declaring to react to severe acquired hypofibrinogenemia (<70 mg/dL) by administering HFC or FFP, respectively. Of the 150 episodes of severe hypofibrinogenemia occurring in 101 patients, 47.3% were treated with HFC and 52.7% with FFP, with a normalization of fibrinogen levels achieved in greater proportion and in a shorter amount of time in the HFC group as compared with the FFP group. None of the patients presented with bleeding or thrombosis during the observation period.

Conclusions: Even with the limitations of the retrospective nature of this study, HFC seems to be a safe and effective alternative to FFP for replacement therapy in case of severe hypofibrinogenemia in children with acute lymphoblastic leukemia.

*Department of Biomedical Science and Human Oncology—Paediatric Unit, Policlinico Hospital

†††Department of Biomedical Science and Human Oncology, University of Bari Aldo Moro

Division of Paediatric Haematology Oncology—Azienda Ospedaliera Universitaria Policlinico Consorziale di Bari, Bari

Paediatric Haematology, Department of Paediatrics, University Hospital Città della Salute e della Scienza di Torino, Torino

§Department of Haematology, Bambino Gesù Children’s Hospital

Department of Cellular Biotechnologies and Haematology, Sapienza University, Rome

Department of Paediatrics, Ospedale S. Gerardo, University of Milano-Bicocca, Fondazione MBBM, Monza

#Department of Paediatric Haemato-Oncology, IRCCS Istituto “Giannina Gaslini,” Genova

**Department of Paediatric Haemato-Oncology, Santobono-Pausilipon Children’s Hospital, Napoli

††Department of Woman and Child Health, Division of Haematology-Oncology, University of Padova, Padova

‡‡Department of Woman, Child and General and Specialized Surgery, Paediatric Oncology Unit, Second University of Naples, Naples

§§Haemato-Oncology Unit, Azienda Ospedaliera “Pugliese-Ciaccio,” Catanzaro

∥∥Paediatric Haemato-Oncology Unit, Ospedale Regionale per le Microcitemie, Cagliari

¶¶Paediatric Onco-Haematology, Hospital of Perugia, Perugia

##Paediatric Onco-Haematology Unit, Spedali Civili, Brescia

***Paediatric Onco-Haematology, Hospital of Pescara, Pescara, Italy

The study received an unrestricted grant from CSL Behring.

The authors declare no conflict of interest.

Reprints: Paola Giordano, MD, Department of Biomedical Science and Human Oncology—Paediatric Unit, Policlinico Hospital, University of Bari Aldo Moro, Piazza Giulio Cesare, 11, Bari 70124, Italy (e-mail:

Received June 26, 2018

Accepted November 13, 2018

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