Evidence map›Paper›PMID 35051831›Full record

Observational studyThrombosis research2022

Clinical characteristics, time course, and outcomes of major bleeding according to bleeding site in patients with venous thromboembolism.

Behnood Bikdeli, Fares Moustafa, José Antonio Nieto, Alfred I Lee, Nuria Ruíz-Giménez, Alicia Lorenzo, Sebastian Schellong, Silvia Soler, Salvador Ortíz, Mª Del Valle Morales and 5 more

Registry-linked trialOpen access · greenAbstract readObservational Study
In one paragraph

Observational study in Thrombosis research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02832245 (Computerized Registry of Patients With Venous Thromboembolism), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT02832245 recruitingnot on this map

Computerized Registry of Patients With Venous Thromboembolism (RIETE)

Typeobservational_patient_registrySponsorManuel MonrealRan2001 to 2027Enrolled120,000ConditionsVenous Thromboembolism
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Age is a Risk Factor for Poor Knowledge About Venous Thromboembolism Treatment.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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

15 authors at 12 institutions in 5 countries.

Behnood BikdeliCardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, USA; Center for Outcomes Research and Evaluation, Yale School of Medicine, New Haven, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: Behnood.bikdeli@yale.edu.
Fares MoustafaDepartment of Emergency, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
José Antonio NietoDepartment of Internal Medicine, Hospital Virgen de la Luz, Cuenca, Spain.
Alfred I LeeSection of Hematology, Department of Internal Medicine, Yale School of Medicine, New Haven, USA.
Nuria Ruíz-GiménezDepartment of Internal Medicine, Hospital Universitario de La Princesa, Madrid, Spain.
Alicia LorenzoDepartment of Internal Medicine, Hospital Universitario La Paz, Madrid, Spain.
Sebastian SchellongDepartment of Medical Clinic, Municipal Hospital of Dresden Friedrichstadt, Dresden, Germany.
Silvia SolerDepartment of Internal Medicine, Hospital Olot i Comarcal de la Garrotxa, Gerona, Spain.
Salvador OrtízUniversidad Autónoma Madrid, S&H Medical Science Service, Madrid, Spain.
Mª Del Valle MoralesDepartment of Internal Medicine, Hospital del Tajo, Madrid, Spain.
Marijan BosevskiInstitute for Cardiovascular Diseases, Faculty of Medicine, Clinical Center, Skopje, Macedonia.
Olga GavínDepartment of Haematology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
Gregory Y H LipLiverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Thrombosis Research Unit, Aalborg University, Aalborg, Denmark.
Manuel MonrealDepartment of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Autónoma de Barcelona, Spain.
RIETE Investigators
Harvard University · USHospital Clínico Universitario Lozano Blesa · ESHospital Comarcal de Inca · ESHospital Universitario de La Princesa · ESHospital Universitario del Tajo · ESHospital Universitario La Paz · ESHospital Virgen de la Luz · ESLiverpool Heart and Chest Hospital · GBStädtisches Klinikum Dresden · DEUniversidad Autónoma de Madrid · ESUniversitat Autònoma de Barcelona · ESYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
POSTDOCTORAL TRAINING IN CARDIOVASCULAR DISEASET32HL007854 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Marwah Abdalla, Michael Argenziano · 1996 to 2026
$14.7M
NCATS NIH HHS UL1 TR001863NHLBI NIH HHS T32 HL007854
6 · The paper itself

Abstract

backgroundBleeding is the most dreaded complication of anticoagulant therapy for acute venous thromboembolism (VTE). Limited data exist about patient characteristics, time course and outcomes of major bleeding, according to the bleeding site.

methodsWe used the data from the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry (03/2001-07/2018) and identified patients who suffered from major bleeding during anticoagulation. We assessed patient characteristics, time course, and 30-day outcomes including mortality, re-bleeding, and VTE recurrences, according to bleeding site.

resultsAmong 78,136 patients with VTE receiving anticoagulation, 2244 (2.9%) suffered from major bleeding (gastrointestinal in 800, intracranial in 417, hematoma in 410, genitourinary in 222, retroperitoneal in 145; other sites in 250). There were variations in baseline characteristics, including older age (P < 0.001) and predominance of women (70.2% [95% confidence interval [CI]]: 65.6-74.6% versus 50.5%, 95% CI: 48.2-52.9, P < 0.001) in patients with hematoma, compared with other patients. Overall, 82.7% of hematomas and 81.4% of retroperitoneal bleeds occurred in the first 90 days after the diagnosis of the VTE event, compared with only 50.6% of intracranial bleeds. Across the bleeding subgroups, 30-day all-cause mortality rates were highest in patients who suffered from intracranial bleeding (41.0%; 99% confidence interval [CI]: 34.8-47.4%), and lowest in patients who suffered from hematoma (17.8%; 99% CI: 13.2-23.2%). Patients who suffered from a major bleeding event in the first 30 days after VTE had significantly higher odds at 90-day follow-up to develop mortality (including from bleeding), recurrent VTE, and recurrent major bleeding (all Ps < 0.001). Variations were observed in the results according to the bleeding site.

conclusionsMajor bleeding is a serious complication in VTE patients. Patient characteristics, time course and outcomes varied substantially according to the bleeding site. Additional studies are needed to tease out the impact of patient risk factors, treatment regimens, and a potential distinct effect from the site of bleeding.

trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02832245 (RIETE registry).

Indexed as

Venous ThromboembolismVenous ThrombosisAnticoagulantsFemaleHemorrhageHumansRecurrenceRegistriesAnticoagulantsBleedingIntracranialOutcomesRetroperitonealSiteVenous thromboembolism

Identifiers

PMID35051831
PMCPMC8891056
OpenAlexW4205321425

What OpenQuestion holds

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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.