Trial reportSurgery2015
Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.
Trial report in Surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.BMC medical research methodology · 2017Pooled it
- A proteomic analysis of NETosis in trauma: Emergence of serpinB1 as a key player.The journal of trauma and acute care surgery · 2023Trial
- Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT.Health technology assessment (Winchester, England) · 2021Trial
- Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial.Lancet (London, England) · 2018Trial
- Combat: Initial Experience with a Randomized Clinical Trial of Plasma-Based Resuscitation in the Field for Traumatic Hemorrhagic Shock.Shock (Augusta, Ga.) · 2015Trial
- The ethics of blood stewardship and quantitative futility assessments to predict certain death in neurotrauma patients.Frontiers in medicine · 2026Review
- A review on the utility of sensitivity analysis in trauma research: Methods and challenges from recent trauma studies.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Review
- Omics Markers of Red Blood Cell Transfusion in Trauma.International journal of molecular sciences · 2022Article
- Article
- Ethical Considerations in Clinical Trials for Disorders of Consciousness.Brain sciences · 2022Article
- Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2021Review
- A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research.EFORT open reviews · 2020Article
- Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants.BMC medical ethics · 2019Article
- Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2019Article
- Protecting study participants in emergency research: is community consultation before trial commencement enough?Trauma surgery & acute care open · 2017Article
- Using social media for community consultation and public disclosure in exception from informed consent trials.The journal of trauma and acute care surgery · 2016Article
- Viscoelastic measurements of platelet function, not fibrinogen function, predicts sensitivity to tissue-type plasminogen activator in trauma patients.Journal of thrombosis and haemostasis : JTH · 2015Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundUp to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study.
methodsThe CC/PD was guided by the four bioethical principles. We used a multimedia approach, including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County's population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (eg, Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT study website.
resultsA total of 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost more than $84,000.
conclusionThe CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.
Indexed as
Identifiers
What OpenQuestion holds
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.