Universität zu Köln

Greiner, Jeanette, Schrappe, Martin, Claviez, Alexander, Zimmermann, Martin, Niemeyer, Charlotte, Kolb, Reinhard, Eberl, Wolfgang, Berthold, Frank, Bergstrasser, Eva, Gnekow, Astrid, Lassay, Elisabeth, Vorwerk, Peter, Lauten, Melchior, Sauerbrey, Axel, Rischewski, Johannes, Beilken, Andreas, Henze, Guenter, Korte, Wolfgang and Moericke, Anja (2019). THROMBOTECT - a randomized study comparing low molecular weight heparin, antithrombin and unfractionated heparin for thromboprophylaxis during induction therapy of acute lymphoblastic leukemia in children and adolescents. Haematologica, 104 (4). S. 756 - 766. PAVIA: FERRATA STORTI FOUNDATION. ISSN 0390-6078

Full text not available from this repository.

Abstract

Thromboembolism is a serious complication of induction therapy for childhood acute lymphoblastic leukemia. We prospectively compared the efficacy and safety of antithrombotic interventions in the consecutive leukemia trials ALL-BFM 2000 and AIEOP-BFM ALL 2009. Patients with newly diagnosed acute lymphoblastic leukemia (n=949, age 1 to 18 years) were randomized to receive low-dose unfractionated heparin, prophylactic low molecular weight heparin (enoxaparin) or activity-adapted antithrombin throughout induction therapy. The primary objective of the study was to determine whether enoxaparin or antithrombin reduces the incidence of thromboembolism as compared to unfractionated heparin. The principal safety outcome was hemorrhage; leukemia outcome was a secondary endpoint. Thromboembolism occurred in 42 patients (4.4%). Patients assigned to unfractionated heparin had a higher risk of throm-boembolism (8.0%) compared with those randomized to enoxaparin (3.5%; P=0.011) or antithrombin (1.9%; P<0.001). The proportion of patients who refused antithrombotic treatment as allocated was 3% in the unfractionated heparin or antithrombin arms, and 33% in the enoxaparin arm. Major hemorrhage occurred in eight patients (no differences between the groups). The 5-year event-free survival was 80.9 +/- 2.2% among patients assigned to antithrombin compared to 85.9 +/- 2.0% in the unfractionated heparin group (P=0.06), and 86.2 +/- 2.0% in the enoxaparin group (P=0.10). In conclusion, prophylactic use of antithrombin or enoxaparin significantly reduced thromboembolism. Despite the considerable number of patients rejecting the assigned treatment with subcutaneous injections, the result remains unambiguous. Thromboprophylaxis - for the present time primarily with enoxaparin - can be recommended for children and adolescents with acute lymphoblastic leukemia during induction therapy. Whether and how antithrombin may affect leukemia outcome remains to be determined.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Greiner, Jeanette UNSPECIFIED UNSPECIFIED UNSPECIFIED Schrappe, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Claviez, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Zimmermann, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Niemeyer, Charlotte UNSPECIFIED UNSPECIFIED UNSPECIFIED Kolb, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Eberl, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Berthold, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Bergstrasser, Eva UNSPECIFIED UNSPECIFIED UNSPECIFIED Gnekow, Astrid UNSPECIFIED UNSPECIFIED UNSPECIFIED Lassay, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Vorwerk, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Lauten, Melchior UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauerbrey, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Rischewski, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Beilken, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Henze, Guenter UNSPECIFIED UNSPECIFIED UNSPECIFIED Korte, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Moericke, Anja UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-153224
DOI:	10.3324/haematol.2018.194175
Journal or Publication Title:	Haematologica
Volume:	104
Number:	4
Page Range:	S. 756 - 766
Date:	2019
Publisher:	FERRATA STORTI FOUNDATION
Place of Publication:	PAVIA
ISSN:	0390-6078
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language L-ASPARAGINASE TREATMENT; CENTRAL VENOUS LINE; AIEOP-BFM; PROPHYLACTIC THERAPY; PEDIATRIC-PATIENTS; RISK; COMPLICATIONS; DISEASE; THROMBOEMBOLISM; METAANALYSIS Multiple languages Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15322