Significance of Disseminated Intravascu… | Clinical Trial

Key information

Conditions

Shock, Septic Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Disseminated intravascular coagulation (DIC) is an acquired syndrome characterized by excessive systemic activation of coagulation, resulting in both hemorrhage and thrombosis. DIC can progress rapidly into lifethreatening multiorgan failure. Under normal hemostatic conditions, clot formation and resolution are tightly regulated. In DIC, dysregulated activation of the coagulation system results in a consumptive coagulopathy and microvascular thrombosis. DIC is always a secondary process caused by a variety of underlying disorders (eg, sepsis, trauma, or malignancy), which can cause endothelial tissue damage and procoagulant exposure .

This activates the coagulation cascade, which promotes fibrin production and deposition and consumption of clotting factors. The subsequent consumption of coagulation factors and platelets, inhibition of natural anticoagulants and fibrinolysis, and fibrin deposition result in the clinical picture of DIC: a bleeding diathesis accompanied by microvascular thrombosis that often leads to end-organ damage . The International Society of Thrombosis and Hemostasis and the Japanese Association for Acute Medicine scoring systems are useful for detection of the DIC in critically ill pediatric patients . The overall incidence of DIC to be 1.2%, using a scoring system comprised of etiologic factors, clinical features, platelet count, prothrombin time, fibrinogen, and fibrin degradation products (FDPs) . The DIC score, easily computed in real-time at the bedside with routine laboratory values, is associated with mortality for children with sepsis andshock.

Diagnosis of DIC through test of the D-dimer. Accordingly, testing for Ddimer or FDPs may be helpful for evulating relationship between DIC score and mortality rate among children with shock .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Children with shock and DIC will developed during the period from 1-1-2025 to 31-12-2025

Exclusion criteria

Any shock not complicated with DIC

Treatment and study plan

D_dimer

Diagnostic Test

DIC score including FDPs,D_dimer

Primary outcomes

Evaluates whether the DIC score, as defined according to the International Society of Thrombosis and Hemostasis guidelines is associated with mortality in Children with shock and DIC

Time frame: Baseline
Data of the patients will be collected in the

form of:
- Personal history (age, sex), demographics including residence.
- Clinical history and examination including diagnoses, vital signs and signs of shock, cause of shock if detected.
- Therapeutic history including the use of continuous vasoactive medications, volume of blood products transfused and the presence of mechanical ventilation
Laboratory investigation:

The four laboratory components of the DIC score were determined from
- Complete blood count (CBC).
- Prothrombin time (PT)
- Platelet count
- FDP titer Scoring systems The score was determined within the first 12 h of admission, at this time the patient was on the highest cumulative dose of these medications and used as a marker for hemodynamic instability. DIC scores were computed when all four-laboratory component
Scoring system

Time frame: Baseline

Component of the score 0 1 2 3 Max points possible

Platelet count (/mm3 ) >100,000 100,000_51 ≤50,000 2 Fibrinogen (mg/dl) ≥100 <100 1 FDP titer (mg/ml) ≤5 6_40 >40 3 prolonged PT (s)<3 3_6 >6 2 Total score 8 All individual components are summed for a total of eight possible points. If d-dimer is used instead of FDP titer, then cutoff values for the DIC score are (0: ≤2 mg/l), (2: 2.1-8 mg/l) and (3: >8 mg/l)

Interpretation of total score:

≥5 points positive for DIC <5 points: negative, but patients could still have "on_ overt DIC" which could evolve into Frank DIC .If there is ongoing concern for DIC, Coagulation labs may be repeated in 12_24 hours.

Secondary outcomes

Sample size

Time frame: Baseline

Eighty (80) children with shock will be included in this study during the period from 1-1-2025 to 31-12-2025. Sample size was calculated by Open Epi Info version (3) according to previous study conducted by Robinder., et al (2008), by comparing two related means using confidence level 85%.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud AbdelFattah Ahmed

CONTACT

[email protected]

01003023766

Nora AbdelHarithAmin

CONTACT

[email protected]

01024463473

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 3, 2024
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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