Evidence map›Paper›PMID 39986609›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2025

Functional disability after clinically significant extracranial bleeding: a secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) Trial.

Darrick K Li, David Cheng, Anna Parks, Meghan L Rieu-Werden, Galina Polekhina, Suzanne E Mahady, M Maria Glymour, Andrew T Chan, Sachin J Shah

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

9 authors.

Darrick K LiSection of Digestive Diseases, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
David ChengBiostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Anna ParksDivision of Hematology & Hematologic Malignances, University of Utah, Salt Lake City, Utah, USA.
Meghan L Rieu-WerdenDivision of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Galina PolekhinaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Suzanne E MahadySchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
M Maria GlymourDepartment of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts, USA.
Andrew T ChanClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, Massachusetts, USA; Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Sachin J ShahCenter for Aging and Serious Illness and Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: sshah@mgh.harvard.edu.

Funding

Main Administrative CoreU19AG062682 · NIA · HENNEPIN HEALTHCARE RESEARCH INSTITUTE · PI CHAN, ANDREW T, MCNEIL, JOHN JAMES · 2019 to 2023
$42.9M
Prospective Study of the Gut Microbiome in AgingRF1AG067744 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI CHAN, ANDREW T · 2020 to 2020
$11.7M
Precision Prevention Research ProgramR35CA253185 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI Andrew T Chan · 2020 to 2026
$6.9M
Individualizing Anticoagulant use in Older Adults with Atrial FibrillationK76AG074919 · NIA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI SHAH, SACHIN J · 2021 to 2025
$1.2M
Advancing patient-centered decision making in older adults with venous thromboembolismK76AG083304 · NIA · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Anna L Parks · 2024 to 2026
$729k
NCI NIH HHS R35 CA253185NIA NIH HHS K76 AG074919NIA NIH HHS K76 AG083304NIA NIH HHS RF1 AG067744NIA NIH HHS U19 AG062682
6 · The paper itself

Abstract

backgroundClinically significant extracranial bleeding, defined as bleeding at any site other than the brain or spinal cord requiring either a hospital admission >24 hours, red blood cell transfusion, surgery for hemostasis, or resulting in death, is a common side effect of antithrombotic agents. Compared to intracranial bleeding, the impact of clinically significant extracranial bleeding on long-term outcomes, including functional independence, has been poorly studied.

objectivesTo determine if clinically significant extracranial bleeding impacts the development of functional disability in healthy older adults.

methodsWe performed a secondary analysis of the Aspirin in Reducing Events in the Elderly trial. The primary outcome of this study was incident dependence in the Katz Activities of Daily Living (ADLs), defined as being unable to perform or requiring assistance with any ADLs or being admitted to a long-term care facility.

resultsA total of 18 982 participants were included in the analysis, of which 547 (2.9%) developed clinically significant extracranial bleeding during study follow-up. In adjusted analyses, clinically significant extracranial bleeding was significantly associated with the development of incident ADL dependence (hazard ratio [HR], 2.46; 95% CI, 1.97-3.07). This finding was similar for gastrointestinal (HR, 2.29; 95% CI, 1.72-2.08) and nongastrointestinal extracranial bleeds (HR, 2.68; 95% CI, 1.96-3.69). The association with increased risk of incident ADL dependence remained significant in secondary analysis of groups randomized to either aspirin (HR, 2.15; 95% CI, 1.57-2.94) or placebo (HR, 2.84; 95% CI, 2.09-3.86).

conclusionClinically significant extracranial bleeding was associated with the development of incident ADL dependence in otherwise healthy older adults.

Indexed as

AspirinFibrinolytic AgentsHemorrhagePlatelet Aggregation InhibitorsActivities of Daily LivingAgedAged, 80 and overAge FactorsDisability EvaluationFemaleHumansMaleRisk FactorsTime FactorsTreatment OutcomeAspirinFibrinolytic AgentsPlatelet Aggregation Inhibitorsdisabilityextracranial bleedingfunctional independence

Identifiers

PMID39986609
PMCPMC12043399

What Socratic 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 Socratic graph.