Evidence map›Paper›PMID 28486976›Full record

Trial reportBMC pediatrics2017

TropicALL study: Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a multicenter randomized controlled trial.

Irene L M Klaassen, Mandy N Lauw, Marianne D van de Wetering, Bart J Biemond, Saskia Middeldorp, Floor C H Abbink, Marc Bierings, D Maroeska M W Te Loo, Rob Pieters, Inge M van der Sluis and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  4. Article
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  6. Review
  7. Thrombotic Complications in Pediatric Cancer.Children (Basel, Switzerland) · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Irene L M KlaassenDepartment of Pediatric Hematology, Academic Medical Center, Amsterdam, The Netherlands.
Mandy N LauwDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Marianne D van de WeteringDepartment of Pediatric Oncology, Academic Medical Center, Amsterdam, The Netherlands.
Bart J BiemondDepartment of Hematology, Academic Medical Center, Amsterdam, The Netherlands.
Saskia MiddeldorpDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Floor C H AbbinkDepartment of Hematology/Oncology, VU Medical Center, Amsterdam, The Netherlands.
Marc BieringsDepartment of Hematology/Oncology, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
D Maroeska M W Te LooDepartment of Pediatric Hematology/Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
Rob PietersPrincess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
Inge M van der SluisDepartment of Pediatric Oncology/Hematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Wim J E TissingDepartment of Pediatric Oncology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, the Netherlands.
C Michel ZwaanDepartment of Pediatric Oncology/Hematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
C Heleen van OmmenDepartment of Pediatric Oncology/Hematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. c.vanommen@erasmusmc.nl.
Academic Medical Center · NLErasmus MC - Sophia Children’s Hospital · NLAmsterdam UMC Location VUmc · NLPrincess Máxima Center · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NLWilhelmina Children's Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVenous thromboembolism (VTE) is a common and severe complication during treatment of acute lymphoblastic leukemia (ALL). An important cause is the intensive use of asparaginase. Prospective cohort studies in which prophylactic low-molecular-weight heparin (LMWH) was used to prevent VTE showed lower VTE risk than in historic control cohorts, with a negligible bleeding risk. However, the efficacy of thromboprophylaxis with LMWH during ALL treatment has never been investigated in a randomized design. Here, we present the protocol of a randomized controlled trial in which the efficacy and safety of thromboprophylaxis with high prophylactic dose LMWH versus no thromboprophylaxis will be assessed in children treated for primary ALL with asparaginase. METHODS/

designThromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin (TropicALL) is a multicenter, randomized controlled open-label trial conducted in the Netherlands. Patients between 1 and 19 years of age with primary ALL, who are treated within the Dutch Childhood Oncology Group (DCOG) ALL-11 or 12 study will be randomized to thromboprophylaxis with LMWH once daily, (dose of 85 IU/kg (intervention arm A)), or to no thromboprophylaxis (arm B, standard of care) during asparaginase courses of ALL treatment. Primary efficacy endpoint is symptomatic objectified VTE during ALL treatment; secondary efficacy endpoints are overall survival and the composite of symptomatic and asymptomatic objectified VTE. Primary safety endpoints are major bleeding, clinically relevant non-major bleeding and minor bleeding. A total of 324 patients will be included to obtain a relative risk reduction of 75% with a power of 80%, using a two-sided test with significance level α = 0.05. DISCUSSION: This trial will be the first to assess efficacy and safety of thromboprophylaxis with LMWH during asparaginase treatment for ALL in children in a randomized design. TRAIL REGISTRATION: Nederlands Trial Register NTR4707 . Registered 30 July 2014.

Indexed as

AdolescentAnticoagulantsAntineoplastic AgentsAsparaginaseChildChild, PreschoolClinical ProtocolsDrug Administration ScheduleFemaleFollow-Up StudiesHeparin, Low-Molecular-WeightHumansInfantMalePrecursor Cell Lymphoblastic Leukemia-LymphomaProspective StudiesAnticoagulantsAntineoplastic AgentsAsparaginaseHeparin, Low-Molecular-WeightAcute lymphoblastic leukemiaAsparaginaseLow molecular weight heparinPediatricVenous thromboembolic disease

Identifiers

PMID28486976
PMCPMC5424373
OpenAlexW2612980656

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.