The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Craniocerebral Trauma Clinical Trial

Official title:

The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461498
• Other study ID #: PB-PG-0808-17148
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: May 29, 2015
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2015
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3556
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 16 years or older

• Blunt head trauma above the neck within 24 hours of ED attendance

• Prescribed warfarin

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injuries, Closed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sheffield	National Institute for Health Research, United Kingdom

References & Publications (23)

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EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Fabbri A, Vandelli A, Servadei F, Marchesini G. Coagulopathy and NICE recommendations for patients with mild head injury. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1787-8. — View Citation

Felli JC, Hazen GB. Sensitivity analysis and the expected value of perfect information. Med Decis Making. 1998 Jan-Mar;18(1):95-109. Erratum in: Med Decis Making. 2003 Jan-Feb;23(1):97.. Med Decis Making 2001 May-Jun;21(3):254. — View Citation

Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001 Dec;10(8):779-87. — View Citation

Ferrera PC, Bartfield JM. Outcomes of anticoagulated trauma patients. Am J Emerg Med. 1999 Mar;17(2):154-6. — View Citation

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. — View Citation

Gittleman AM, Ortiz AO, Keating DP, Katz DS. Indications for CT in patients receiving anticoagulation after head trauma. AJNR Am J Neuroradiol. 2005 Mar;26(3):603-6. — View Citation

Hart RG, Boop BS, Anderson DC. Oral anticoagulants and intracranial hemorrhage. Facts and hypotheses. Stroke. 1995 Aug;26(8):1471-7. Review. — View Citation

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. — View Citation

Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med. 1994 Jun 1;120(11):897-902. — View Citation

Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med. 1993 Sep;95(3):315-28. Review. — View Citation

Lavoie A, Ratte S, Clas D, Demers J, Moore L, Martin M, Bergeron E. Preinjury warfarin use among elderly patients with closed head injuries in a trauma center. J Trauma. 2004 Apr;56(4):802-7. — View Citation

Li J, Brown J, Levine M. Mild head injury, anticoagulants, and risk of intracranial injury. Lancet. 2001 Mar 10;357(9258):771-2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Teasdale G, Murray G, Parker L, Jennett B. Adding up the Glasgow Coma Score. Acta Neurochir Suppl (Wien). 1979;28(1):13-6. — View Citation

Volans AP. The risks of minor head injury in the warfarinised patient. J Accid Emerg Med. 1998 May;15(3):159-61. — View Citation

Wilson JT, Edwards P, Fiddes H, Stewart E, Teasdale GM. Reliability of postal questionnaires for the Glasgow Outcome Scale. J Neurotrauma. 2002 Sep;19(9):999-1005. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	No
Secondary	Prevalence of ongoing symptoms relating to the head injury	Impaired activities of daily living (assessed by the EQ5D)	18 months	No
Secondary	Prevalence of ongoing symptoms relating to the head injury	Headache symptoms	18 months	No
Secondary	Prevalence of ongoing symptoms relating to the head injury	Impaired cognitive function (assessed by the Glasgow Outcome Scale)	18 months	No
Secondary	Identification of early predictors of adverse clinical outcome	Including clinical features and initial investigations which may be useful as a diagnostic tool.	18 months	No