NCT07023705

Brief Summary

A retrospective study to assess the utility of hematological marker (monocyte to large platelet ratio) to diagnose patients with pulmonary embolism

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 9, 2025

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monocyte-to-Large Platelet Ratio (MLPR)

    A ratio between monocyte absolute count and the large platelets count (MLPR) values compared between groups using Mann-Whitney U test; diagnostic accuracy evaluated by area under the curve (AUC) , sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

    At emergency department admission (baseline lab measurement) before any treatment.

Secondary Outcomes (5)

  • Mean platelet volume (MPV)

    At emergency department admission (baseline lab measurement) before any treatment.

  • Neutrophil to Lymphocyte Ratio (NLR)

    At emergency department admission (baseline lab measurement) before any treatment.

  • D-Dimer Levels

    At emergency department admission (baseline lab measurement) before any treatment.

  • Platelet Distribution Width (PDW)

    At emergency department admission (baseline lab measurement) before any treatment.

  • Platelet To Lymphocyte Ratio (PLR)

    At emergency department admission (baseline lab measurement) before any treatment.

Study Arms (2)

Pulmonary embolism

Group that is confirmed to have pulmonary embolism by positive CTPA finding filling defect.

Diagnostic Test: Monocyte to Large Platelet Ratio (MLPR)

Non-Pulmonary embolism

Group that have pulmonary embolism diagnosis was excluded by negative CTPA finding.

Diagnostic Test: Monocyte to Large Platelet Ratio (MLPR)

Interventions

Admission laboratory values were used to calculate the Monocyte-to-Large Platelet Ratio (MLPR) by dividing the absolute monocyte count by the large platelet count. These values were obtained from blood samples collected before any treatment was administered.

Non-Pulmonary embolismPulmonary embolism

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department with signs and symptoms of pulmonary embolism who underwent CT pulmonary angiography for diagnosis.

You may qualify if:

  • Only patients with the results of full blood count and white blood cell differentiation, measured before the treatment of suspected PE.
  • Patients underwent CT pulmonary angiography to confirm or exclude pulmonary embolism diagnosis.

You may not qualify if:

  • Patient with history of any myeloproliferative disorder, myelofibrosis, Glanzmann thrombasthenia, May-Hegglin anomaly, Bernard-Soulier syndrome, suspicion of disseminated intravascular coagulation.
  • Patient receiving any anticoagulant drug at a therapeutic dose.
  • Patient with blood transfusion in the last 2 months.
  • Patients with acute coronary syndrome, pulmonary edema.
  • Patient on immunosuppressive drugs , Oral contraceptive pills .
  • Patients with severe renal or hepatic disease.
  • Patients with Stroke.
  • Patients with malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (4)

  • Granger V, Faille D, Marani V, Noel B, Gallais Y, Szely N, Flament H, Pallardy M, Chollet-Martin S, de Chaisemartin L. Human blood monocytes are able to form extracellular traps. J Leukoc Biol. 2017 Sep;102(3):775-781. doi: 10.1189/jlb.3MA0916-411R. Epub 2017 May 2.

    PMID: 28465447BACKGROUND
  • Moharamzadeh P, Rahmani F, Foroughifar S, Shahsavarinia K. Reliability of Platelet Indices for Diagnosing Pulmonary Embolism; a Brief Report. Adv J Emerg Med. 2019 Apr 28;3(3):e27. doi: 10.22114/ajem.v0i0.137. eCollection 2019 Summer.

    PMID: 31410404BACKGROUND
  • Talay F, Ocak T, Alcelik A, Erkuran K, Akkaya A, Duran A, Demirhan A, Kar Kurt O, Asuk Z. A new diagnostic marker for acute pulmonary embolism in emergency department: mean platelet volume. Afr Health Sci. 2014 Mar;14(1):94-9. doi: 10.4314/ahs.v14i1.15.

    PMID: 26060464BACKGROUND
  • Bialas AJ, Kornicki K, Ciebiada M, Antczak A, Sitarek P, Milkowska-Dymanowska J, Piotrowski WJ, Gorski P. Monocyte to large platelet ratio as a diagnostic tool for pulmonary embolism in patients with acute exacerbation of chronic obstructive pulmonary disease. Pol Arch Intern Med. 2018 Jan 31;128(1):15-23. doi: 10.20452/pamw.4141. Epub 2017 Nov 7.

MeSH Terms

Conditions

Pulmonary EmbolismDisease

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Reem H Elkabarity, Professor

    Ain Shams University

    STUDY CHAIR
  • Hadil M Abdelhamid, Professor

    Ain Shams University

    STUDY DIRECTOR
  • Azza Lotfy, Professor

    Ain Shams University

    STUDY DIRECTOR
  • Mohamed k Awad, Lecturer

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations