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Craniocerebral TraumaNCT02461498

The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

An observational study of Craniocerebral Trauma and Head Injuries, Closed, run by University of Sheffield.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Craniocerebral Trauma, Head Injuries, Closed
How many people
3,556 participants
Where
No sites listed yet
Study dates
Jul 2011to Mar 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Adults who attend participating emergency departments (ED) with a head injury and also prescribed warfarin

Who may be able to join

  • 16 years or older
  • Blunt head trauma above the neck within 24 hours of ED attendance
  • Prescribed warfarin

Who cannot join

  • Penetrating injuries to the head, for example knife wound.

About this study

Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. The investigators aimed to undertake research in order to understand the range and frequency of outcomes following head injury in this group of patients and to develop robust clinical guidance for how they should be optimally managed in the future.

Read the detailed description

This prospective observational study aims to enrol patients taking warfarin that attend participating ED's (up to 33) in England and Scotland after blunt head injury. Over an 18-month period from Oct 2011, ED attendance data will be collected from each ED as well as information from patient questionnaires about the care the patient received and the status of their health 6-10 weeks after the injury. Patients who died due to their head injury, experienced surgery due to their injury, had a change identified on a CT scan or re-attended the ED with a clear head injury complication are defined as experiencing a poor outcome. Information such as the patients' conscious state (GCS), level of clotting in their blood (INR) and symptoms will be investigated as predictors of a poor outcome. A mathematical model will be used to estimate the most cost-effective strategy assuming published National Institute for Health and Care Excellence (NICE) thresholds for cost per quality adjusted life year (QALY).

Keywords
Warfarin
Medical subject headings
Craniocerebral Trauma, Head Injuries, Closed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of head injury complication in study cohort

    Head injury complications defined as death or neurosurgery resulting from the initial injury, a clinically-significant CT scan finding or re-attendance to the ED with a significant head injury-related complication up to 10 weeks after the original attendance.

    Measured: 18 months

Secondary outcomes (4)

  1. Prevalence of ongoing symptoms relating to the head injury

    Impaired activities of daily living (assessed by the EQ5D)

    Measured: 18 months

  2. Prevalence of ongoing symptoms relating to the head injury

    Headache symptoms

    Measured: 18 months

  3. Prevalence of ongoing symptoms relating to the head injury

    Impaired cognitive function (assessed by the Glasgow Outcome Scale)

    Measured: 18 months

  4. Identification of early predictors of adverse clinical outcome

    Including clinical features and initial investigations which may be useful as a diagnostic tool.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461498
Sponsor's protocol ID
PB-PG-0808-17148
Status last verified
May 2015
First submitted
27 May 2015
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Saab M, Gray A, Hodgkinson D, Irfan M. Warfarin and the apparent minor head injury. J Accid Emerg Med. 1996 May;13(3):208-9. doi: 10.1136/emj.13.3.208.

    PubMed 8733663

  • Stiell IG, Wells GA, Vandemheen K, Clement C, Lesiuk H, Laupacis A, McKnight RD, Verbeek R, Brison R, Cass D, Eisenhauer ME, Greenberg G, Worthington J. The Canadian CT Head Rule for patients with minor head injury. Lancet. 2001 May 5;357(9266):1391-6. doi: 10.1016/s0140-6736(00)04561-x.

    PubMed 11356436

  • Haydel MJ, Preston CA, Mills TJ, Luber S, Blaudeau E, DeBlieux PM. Indications for computed tomography in patients with minor head injury. N Engl J Med. 2000 Jul 13;343(2):100-5. doi: 10.1056/NEJM200007133430204.

    PubMed 10891517

  • Mower WR, Hoffman JR, Herbert M, Wolfson AB, Pollack CV Jr, Zucker MI; NEXUS II Investigators. National Emergency X-Radiography Utilization Study. Developing a clinical decision instrument to rule out intracranial injuries in patients with minor head trauma: methodology of the NEXUS II investigation. Ann Emerg Med. 2002 Nov;40(5):505-14. doi: 10.1067/mem.2002.129245.

    PubMed 12399794

  • Volans AP. The risks of minor head injury in the warfarinised patient. J Accid Emerg Med. 1998 May;15(3):159-61. doi: 10.1136/emj.15.3.159.

    PubMed 9639176

  • Hart RG, Boop BS, Anderson DC. Oral anticoagulants and intracranial hemorrhage. Facts and hypotheses. Stroke. 1995 Aug;26(8):1471-7. doi: 10.1161/01.str.26.8.1471.

    PubMed 7631356

  • Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med. 1994 Jun 1;120(11):897-902. doi: 10.7326/0003-4819-120-11-199406010-00001.

    PubMed 8172435

  • Ferrera PC, Bartfield JM. Outcomes of anticoagulated trauma patients. Am J Emerg Med. 1999 Mar;17(2):154-6. doi: 10.1016/s0735-6757(99)90050-5.

    PubMed 10102316

  • Mathiesen T, Benediktsdottir K, Johnsson H, Lindqvist M, von Holst H. Intracranial traumatic and non-traumatic haemorrhagic complications of warfarin treatment. Acta Neurol Scand. 1995 Mar;91(3):208-14. doi: 10.1111/j.1600-0404.1995.tb00436.x.

    PubMed 7793238

  • National Collaborating Centre for Acute Care (UK). Head Injury: Triage, Assessment, Investigation and Early Management of Head Injury in Infants, Children and Adults. London: National Collaborating Centre for Acute Care (UK); 2007 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK53036/

    PubMed 21563330

  • Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.

    PubMed 9726257

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med. 1993 Sep;95(3):315-28. doi: 10.1016/0002-9343(93)90285-w.

    PubMed 8368229

  • Fortuna GR, Mueller EW, James LE, Shutter LA, Butler KL. The impact of preinjury antiplatelet and anticoagulant pharmacotherapy on outcomes in elderly patients with hemorrhagic brain injury. Surgery. 2008 Oct;144(4):598-603; discussion 603-5. doi: 10.1016/j.surg.2008.06.009. Epub 2008 Aug 29.

    PubMed 18847644

  • Li J, Brown J, Levine M. Mild head injury, anticoagulants, and risk of intracranial injury. Lancet. 2001 Mar 10;357(9258):771-2. doi: 10.1016/S0140-6736(00)04163-5.

    PubMed 11253975

Questions about this trial

What is this clinical trial studying?

An observational study of Craniocerebral Trauma and Head Injuries, Closed, run by University of Sheffield.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of head injury complication in study cohort (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02461498, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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