Evidence map›Paper›PMID 35491419›Full record

ArticleNeurological research and practice2022

Intracranial bleeding under vitamin K antagonists or direct oral anticoagulants: results of the RADOA registry.

Waltraud Pfeilschifter, Edelgard Lindhoff-Last, Ali Alhashim, Barbara Zydek, Simone Lindau, Stavros Konstantinides, Oliver Grottke, Ulrike Nowak-Göttl, Christian von Heymann, Ingvild Birschmann and 5 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Neurological research and practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01722786 (Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT01722786 completednot on this map

Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists

TypeobservationalSponsorCardioangiologisches Centrum BethanienRan2014 to 2019Enrolled272ConditionsSevere Bleeding, Urgent Surgery
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

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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

15 authors at 8 institutions in 4 countries.

Waltraud Pfeilschifter *Department of Neurology and Clinical Neurophysiology, Klinikum Lueneburg, Bögelstr. 1, 21339, Lüneburg, Germany. waltraud.pfeilschifter@klinikum-lueneburg.de.ORCID http://orcid.org/0000-0001-6935-8842
Edelgard Lindhoff-Last *Coagulation Centre and Coagulation Research Center at the Cardiology Angiology Centre Bethanien Hospital (CCB), Im Prüfling 23, 60389, Frankfurt, Germany. e.lindhoff-last@ccb.de.
Ali AlhashimDepartment of Neurology, University Hospital Frankfurt, Frankfurt, Germany.
Barbara ZydekCoagulation Centre and Coagulation Research Center at the Cardiology Angiology Centre Bethanien Hospital (CCB), Im Prüfling 23, 60389, Frankfurt, Germany.
Simone LindauDepartment of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Stavros KonstantinidesCenter for Thrombosis and Haemostasis (CTH), Johannes Gutenberg University, Mainz, Germany.
Oliver GrottkeDepartment of Anaesthesiology, RWTH Aachen University Hospital, Aachen, Germany.
Ulrike Nowak-GöttlInstitute of Clinical Chemistry, Thrombosis and Haemostasis Treatment Centre, University Hospital, Kiel-Lübeck, Germany.
Christian von HeymannDepartment of Anaesthesia, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Ingvild BirschmannInstitute for Laboratory and Transfusion Medicine, Heart and Diabetes Centre, Ruhr University, Bochum, Germany.
Jan Beyer-WestendorfThrombosis Research Unit, Department of Medicine 1; Division Haematology, Dresden University Clinic, Dresden, Germany.
Patrick MeybohmDepartment of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Andreas GreinacherDepartment of Immunology and Transfusion Medicine, Universitätsmedizin, Greifswald, Germany.
Eva HerrmannInstitute of Biostatistics and Mathematical Modelling, Goethe University, Frankfurt, Germany.
RADOA-Registry Investigators (Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists Registry)
Goethe University Frankfurt · DECardiovascular Center Bethanien · DEJohannes Gutenberg University Mainz · DEKing's College - North Carolina · USKlinikum im Friedrichshain · DERuhr University Bochum · DEUniversitätsklinikum Aachen · DEUniversitätsmedizin Greifswald · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThe use of direct oral anticoagulants (DOAC) has increased sharply and DOAC are the oral anticoagulant therapy (OAT) of choice for the majority of patients with newly-diagnosed atrial fibrillation. Intracranial hemorrhage is the most severe adverse event of OAT. Systematic data on the course of intracranial hemorrhage under DOAC compared to vitamin K antagonists (VKA) are warranted to enable shared decision making in AF patients needing OAT.

methodsThis is a secondary analysis of the patients with intracranial bleedings from the prospective multicenter emergency department-based RADOA registry, which collected data on patients admitted with major bleeding while taking VKA or DOAC. The primary endpoint was in-hospital mortality until day 30. We evaluated hematoma volume and short-term clinical outcomes in relation to the extent of active OAT according to coagulation parameters and OAT plasma levels measured by UPLC-MS/MS.

resultsOf 193 patients with major bleeding, 109 (56.5%) had intracranial hemorrhage [52.3% intracerebral (ICH), 33.9% subdural (SDH), 11.0% subarachnoidal (SAH)]. 64 (58.7%) were on VKA and 45 (41.2%) were on DOAC. On admission, we could confirm active anticoagulation in 97.7% of VKA-treated patients based on either INR > 1.3 or phenprocoumon levels and in 75.8% of DOAC-treated patients based on DOAC levels. Patients suffering an intracranial hemorrhage under VKA showed significantly larger hematoma volumes and a higher in-hospital mortality. Especially in intracerebral hemorrhage, we observed a higher initial severity and numerically greater proportion of early changes towards palliative therapy under VKA, which coincided with a numerically higher case fatality.

conclusionsWe show significantly smaller hematoma volumes for ICH and SDH under DOAC in comparison to VKA and a significantly lower 30-day in-hospital mortality rate of DOAC-ICH, even before the introduction of specific antidotes. These data strongly support the use of DOAC whenever possible in patients requiring OAT.

trial registrationhttp://www. CLINICALTRIALS: gov ; Unique identifier: NCT01722786.

Identifiers

PMID35491419
PMCPMC9059415
OpenAlexW4225287028

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.