Out-of-hospital Cardiac Arrest (OHCA) Biomarkers

NCT03112486 | Completed

• 1 other identifier: IRB201700133
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Few early prognostic indicators are currently available for patients' families and clinicians following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic value in these cases. Brain tissue is highly dependent upon aerobic respiration, and oxygen deprivation result in irreversible neuronal cell injury. Peptides released into the blood by injured neuronal cells can be measured to estimate degree of injury, and potentially predict long term neurological outcome.

Conditions

Neurological Outcome; Cardiac Arrest; Out-Of-Hospital Cardiac Arrest; Brain Anoxia Ischemia; Hypoxia, Brain; Hypoxia-Ischemia, Brain; Cardiac Arrest With Successful Resuscitation; Cardiac Arrest, Out-Of-Hospital; Brain Injuries

Keywords

out-of-hospital cardiac arrest; neurological outcome; prognostication; cerebral performance category; hypoxic-ischemic brain injury; biomarkers

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Higher blood biomarker levels will correlate with reduced rate of survival to hospital admission, survival to hospital discharge, and 6-month survival.

  1 year

Secondary Outcomes (2)

• Functional neurological outcome at discharge

  1 year

• Functional neurological outcome at 6 months after discharge

  1 year

Other Outcomes (1)

• Influence of renal and liver disease on blood biomarker(s) level post-OHCA

  1 year

Study Arms (2)

Cardiac Arrest cohort

adult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest

Procedure: blood draw

Control cohort

matched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints).

Procedure: blood draw

Interventions

blood draw PROCEDURE

Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL).

Cardiac Arrest cohort; Control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include all adult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest. Exclusions will include patients with advanced directives precluding resuscitation, traumatic cardiac arrest, and irreversible signs of death (e.g. rigor mortis). A matched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints). Blood draws in this cohort will be collected as per protocol and will end upon the termination of medical care or as per protocol - whichever is of the least duration.

You may qualify if:

• \- \>18 years old
• Study cohort:
• Non-traumatic out of hospital cardiac arrest
• Control cohort:
• Chest pain of non-cardiac etiology

You may not qualify if:

• Both cohorts:
• Females of child bearing age with positive pregnancy test
• Neurodegenerative disease or other neurological disorder (dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumours)
• History of neurosurgery within the last 30 days Acute brain injury within the last 30 days (ischemic/ haemorrhagic stroke, traumatic brain injury) Subject is anemic OR donated blood within the last 8 weeks OR has a hematological disorder that requires transfusions Subject has history of liver failure OR renal failure
• Study cohort:
• Advanced directives against resuscitation Traumatic cardiac arrest In hospital cardiac arrest Failure to attain ROSC + visible signs of death (livor mortis, rigor mortis)
• Control cohort:
• EKG changes: New ST-elevation consistent with myocardial infarction NSTEMI Hemodynamically unstable

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Univeristy of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (13)

• Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

  PMID: 26673558 BACKGROUND

• Sasson C, Hegg AJ, Macy M, Park A, Kellermann A, McNally B; CARES Surveillance Group. Prehospital termination of resuscitation in cases of refractory out-of-hospital cardiac arrest. JAMA. 2008 Sep 24;300(12):1432-8. doi: 10.1001/jama.300.12.1432.

  PMID: 18812534 BACKGROUND

• Chan PS, McNally B, Tang F, Kellermann A; CARES Surveillance Group. Recent trends in survival from out-of-hospital cardiac arrest in the United States. Circulation. 2014 Nov 18;130(21):1876-82. doi: 10.1161/CIRCULATIONAHA.114.009711.

  PMID: 25399396 BACKGROUND

• Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.

  PMID: 18948368 BACKGROUND

• Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.

  PMID: 15365608 BACKGROUND

• Moulaert VR, Verbunt JA, van Heugten CM, Wade DT. Cognitive impairments in survivors of out-of-hospital cardiac arrest: a systematic review. Resuscitation. 2009 Mar;80(3):297-305. doi: 10.1016/j.resuscitation.2008.10.034. Epub 2008 Dec 30.

  PMID: 19117659 BACKGROUND

• Lim C, Verfaellie M, Schnyer D, Lafleche G, Alexander MP. Recovery, long-term cognitive outcome and quality of life following out-of-hospital cardiac arrest. J Rehabil Med. 2014 Jul;46(7):691-7. doi: 10.2340/16501977-1816.

  PMID: 24849762 BACKGROUND

• Larsson IM, Wallin E, Rubertsson S, Kristofferzon ML. Health-related quality of life improves during the first six months after cardiac arrest and hypothermia treatment. Resuscitation. 2014 Feb;85(2):215-20. doi: 10.1016/j.resuscitation.2013.09.017. Epub 2013 Oct 2.

  PMID: 24096198 BACKGROUND

• Pusswald G, Fertl E, Faltl M, Auff E. Neurological rehabilitation of severely disabled cardiac arrest survivors. Part II. Life situation of patients and families after treatment. Resuscitation. 2000 Nov;47(3):241-8. doi: 10.1016/s0300-9572(00)00240-9.

  PMID: 11114453 BACKGROUND

• Sandroni C, Cavallaro F, Callaway CW, Sanna T, D'Arrigo S, Kuiper M, Della Marca G, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 1: patients not treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1310-23. doi: 10.1016/j.resuscitation.2013.05.013. Epub 2013 Jun 27.

  PMID: 23811182 BACKGROUND

• Sandroni C, Cavallaro F, Callaway CW, D'Arrigo S, Sanna T, Kuiper MA, Biancone M, Della Marca G, Farcomeni A, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 2: Patients treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1324-38. doi: 10.1016/j.resuscitation.2013.06.020. Epub 2013 Jul 3.

  PMID: 23831242 BACKGROUND

• Sandroni C, Geocadin RG. Neurological prognostication after cardiac arrest. Curr Opin Crit Care. 2015 Jun;21(3):209-14. doi: 10.1097/MCC.0000000000000202.

  PMID: 25922894 BACKGROUND

• Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Huei-Ming Ma M, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Eng Hock Ong M, Travers AH, Nolan JP; Utstein Collaborators. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals from a task force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Circulation. 2015 Sep 29;132(13):1286-300. doi: 10.1161/CIR.0000000000000144. Epub 2014 Nov 11.

  PMID: 25391522 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood biomarkers

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest; Hypoxia-Ischemia, Brain; Hypoxia, Brain; Brain Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Joseph A Tyndall, MD, MPH

  Chairman Department Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: May 26, 2017
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

US (1)