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ASpirin as a Treatment for ARDS (STAR): a Phase 2 Randomised Control Trial

NCT02326350 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-03-13

No results posted yet for this study

Summary

Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through their inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. Blood cells called platelets have increasingly been recognized to play a key role in the development of ARDS. There is increasing information that aspirin, a drug which is widely used to treat heart disease, might be important in treating ARDS. We plan to test if aspirin will help in the treatment of ARDS. To do this we will divide patients suffering from ARDS into two groups, one of which will get aspirin and the other a harmless dummy (or placebo) tablet who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if aspirin is effective in patients with ARDS. This project will also provide new information about mechanisms in the development of ARDS leading, potentially, to other new treatments.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Aspirin 75mg

Active treatment

DRUG

Lactose powder

Placebo

Sponsors & Collaborators

  • Queen's University, Belfast

    collaborator OTHER

  • Northern Ireland Clinical Trials Unit

    collaborator OTHER

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Danny F McAuley, Professor · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-06
Primary Completion
2018-11-23
Completion
2018-11-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326350 on ClinicalTrials.gov