Evidence map›Paper›PMID 35909257›Full record

ArticleThrombosis and haemostasis2022

Anticoagulant Effects of Dabigatran on Coagulation Laboratory Parameters in Pediatric Patients: Combined Data from Five Pediatric Clinical Trials.

Lesley G Mitchell, Daniel Röshammar, Fenglei Huang, Manuela Albisetti, Leonardo R Brandão, Lisa Bomgaars, Elizabeth Chalmers, Jacqueline Halton, Matteo Luciani, David Joseph and 3 more

Open access · hybridAbstract read
In one paragraph

Article in Thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Guideline
  2. Article
  3. The value of the old and the new.Blood advances · 2023
    Article
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 9 institutions in 6 countries.

Lesley G MitchellDepartment of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Daniel RöshammarPharmetheus AB, Uppsala, Sweden.
Fenglei HuangTranslational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States.
Manuela AlbisettiHematology Department, University Children's Hospital, Zürich, Switzerland.
Leonardo R BrandãoDivision of Hematology/Oncology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Lisa BomgaarsDepartment of Pediatrics, Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas, United States.
Elizabeth ChalmersThe Glasgow Children's Haemophilia Unit, Royal Hospital for Children, Glasgow, Scotland, United Kingdom.
Jacqueline HaltonDivision of Hematology/Oncology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
Matteo LucianiPediatric Hematology/Oncology Department, Pediatric Hospital Bambino Gesù, Rome, Italy.
David JosephTranslational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States.
Igor TartakovskyTherapeutic Area Cardiovascular Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Savion GropperTherapeutic Area Inflammation Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Martina BrueckmannTherapeutic Area Cardiovascular Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USBambino Gesù Children's Hospital · ITBaylor College of Medicine · USRoyal Hospital for Children · GBUniversity Children's Hospital Zurich · CHUniversity of Alberta · CAUniversity of Ottawa · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDabigatran etexilate, a direct oral thrombin inhibitor, is approved to treat venous thromboembolism (VTE) in both adults and children.

objectivesThis population analysis characterized relationships between dabigatran total plasma concentrations and coagulation laboratory parameters (activated partial thromboplastin time [aPTT]; diluted thrombin time [dTT]; ecarin clotting time [ECT]).

methodsData from three phase 2a and one single-arm and one randomized, comparative phase 2b/3 pediatric studies (measurements: aPTT 2,925 [

resultsOverall, relationships between dabigatran, aPTT, dTT, and ECT were similar in children and adults. For children aged <6 months, a higher proportion of baseline samples were outside or close to the upper aPTT and ECT adult ranges. No age-related differences were detected for dTT. With increasing dabigatran concentration, aPTT rose nonlinearly (half the maximum effect at 368 ng/mL dabigatran) while dTT and ECT increased linearly (0.37 and 0.73% change per ng/mL dabigatran, respectively). Mean baseline aPTT (45 vs. 36 seconds) and ECT (40 vs. 36 seconds) were slightly increased for those aged <6 months versus older children.

conclusionThe similar relationships of laboratory parameters observed across pediatric age groups suggests that developmental changes in the hemostatic system may have little effect on response to dabigatran.

Indexed as

AnticoagulantsDabigatranAdolescentAntithrombinsBlood CoagulationBlood Coagulation TestsChildChild, PreschoolClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicFemaleHumansInfantMalePartial Thromboplastin TimeRandomized Controlled Trials as TopicAnticoagulantsAntithrombinsDabigatran

Identifiers

PMID35909257
PMCPMC9420551
OpenAlexW4289132443

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.