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RecruitingNCT04251247Updated Mar 15, 2024

Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection

An observational study in Aortic Dissection and Pulmonary Embolism, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
159
Ages
18 Years and older
Sex
All
01

Study summary

Acute aortic dissection is rare but potentially life-threatening disease with an incidence of 5-30 cases per million, annually. Therefore prompt diagnosis is crucial. D-dimer values have been shown to be useful in the diagnosis of acute aortic dissection. Fibrinogen levels have been shown to be low, normal or high in individuals with acute aortic dissection. This study aims to investigate whether D-dimer/fibrinogen ratio can be valuable for diagnosis of acute aortic dissection.

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Conditions studied

  • Aortic Dissection
  • Pulmonary Embolism
03

In context

Aortic Dissection

205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.

This study's planned enrollment of 159 is below the median of 230 across 115 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults presenting to emergency department with chest pain.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of acute aortic dissection
  • Diagnosis of acute pulmonary embolism
  • Diagnosis of non-cardiac chest pain

Exclusion criteria

Exclusion Criteria:

  • Any etiology of chest pain other than acute aortic dissection, acute pulmonary embolism, or non-cardiac chest pain
  • Participants who do not give consent for enrollment
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
159 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute aortic dissection

    Patients with a diagnosis of acute aortic dissection.

    Diagnostic Test: D-dimer/fibrinogen ratio

  • Acute pulmonary embolism

    Patients with a diagnosis of acute pulmonary embolism

    Diagnostic Test: D-dimer/fibrinogen ratio

  • Non-cardiac chest pain

    Patients with non-cardiac chest pain

    Diagnostic Test: D-dimer/fibrinogen ratio

Interventions

  • Diagnostic testD-dimer/fibrinogen ratio

    The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)

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What researchers measure

Primary outcomes

  1. Acute aortic dissection

    Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography

    Time frame: 24 hours

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Study locations

2 of 2 sites recruiting
  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
    Istanbul, 34668, Turkey
    Recruiting
  • Kartal Dr. Lutfi Kirdar Training and Research Hospital
    Istanbul, 34890, Turkey
    Recruiting
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References and documents

Publications

  • Hajsadeghi S, Kerman SR, Khojandi M, Vaferi H, Ramezani R, Jourshari NM, Mousavi SA, Pouraliakbar H. Accuracy of D-dimer:fibrinogen ratio to diagnose pulmonary thromboembolism in patients admitted to intensive care units. Cardiovasc J Afr. 2012 Sep;23(8):446-56. doi: 10.5830/CVJA-2012-041. PubMed 23044500 ↗
  • Kara H, Bayir A, Degirmenci S, Kayis SA, Akinci M, Ak A, Celik B, Dogru A, Ozturk B. D-dimer and D-dimer/fibrinogen ratio in predicting pulmonary embolism in patients evaluated in a hospital emergency department. Acta Clin Belg. 2014 Aug;69(4):240-5. doi: 10.1179/2295333714Y.0000000029. PubMed 25012747 ↗
  • Guan XL, Wang XL, Liu YY, Lan F, Gong M, Li HY, Liu O, Jiang WJ, Liu YM, Zhu JM, Sun LZ, Zhang HJ. Changes in the Hemostatic System of Patients With Acute Aortic Dissection Undergoing Aortic Arch Surgery. Ann Thorac Surg. 2016 Mar;101(3):945-51. doi: 10.1016/j.athoracsur.2015.08.047. Epub 2015 Oct 23. PubMed 26603023 ↗
  • Eggebrecht H, Naber CK, Bruch C, Kroger K, von Birgelen C, Schmermund A, Wichert M, Bartel T, Mann K, Erbel R. Value of plasma fibrin D-dimers for detection of acute aortic dissection. J Am Coll Cardiol. 2004 Aug 18;44(4):804-9. doi: 10.1016/j.jacc.2004.04.053. PubMed 15312863 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04251247
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Ahmet Can Topcu (Director of Department of Cardiovascular Surgery, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Jan 31, 2020
Start date
Mar 1, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Mar 15, 2024

Study contacts

Avni Uygar Seyhan, M.D.
Contact
uygarseyhan@gmail.com
902164583000 ext. 30202
Ahmet Can Topcu, M.D.
Contact
ahmetcan1987@gmail.com
902164583000 ext. 22105

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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