Significance of Disseminated Intravascular Coagulation Score in Mortality for Children With Shock

NCT06581172 | Not Yet Recruiting

• 1 other identifier: DIC
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Shock, Septic

Keywords

DIC score

Outcome Measures

Primary Outcomes (2)

• 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

  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 1. Complete blood count (CBC). 2. Prothrombin time (PT) 3. Platelet count 4. 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

  Baseline

• Scoring system

  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.

  Baseline

Secondary Outcomes (1)

• Sample size

  Baseline

Interventions

D_dimer DIAGNOSTIC_TEST

DIC score including FDPs,D\_dimer

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with shock and DIC

You may qualify if:

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

You may not qualify if:

• Any shock not complicated with DIC

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Chanthong S, Choed-Amphai C, Manowong S, Tuntivate P, Tansriratanawong S, Makonkawkeyoon K, Natesirinilkul R. Rotational Thromboelastometry and Clot Waveform Analysis as Point-of-Care Tests for Diagnosis of Disseminated Intravascular Coagulation in Critically Ill Children in Thailand. Pediatr Crit Care Med. 2024 May 1;25(5):e221-e231. doi: 10.1097/PCC.0000000000003452. Epub 2024 Feb 1.

  PMID: 38299935 BACKGROUND

• Infante, J. B., Esteves, G. V., Raposo, J., & de Lacerda, J. F. (2024)

  BACKGROUND

• Kim, T. W., Ko, R. E., Choi, K. H., Chung, C. R., Cho, Y. H., & Yang, J. H. (2024)

  BACKGROUND

• Zafar A, Naeem F, Khalid MZ, Awan S, Riaz MM, Mahmood SBZ. Comparison of five different disseminated intravascular coagulation criteria in predicting mortality in patients with sepsis. PLoS One. 2024 Mar 7;19(3):e0295050. doi: 10.1371/journal.pone.0295050. eCollection 2024.

  PMID: 38452037 BACKGROUND

• Rashad, A. B., Habib, M. S., Saleh, N. Y., & Abo El Fotoh, W. M. (2023)

  BACKGROUND

• Songthawee N, Chavananon S, Sripornsawan P, McNeil E, Chotsampancharoen T. Prevalence and risk factors of disseminated intravascular coagulation in childhood acute lymphoblastic leukemia. Pediatr Res. 2023 Aug;94(2):588-593. doi: 10.1038/s41390-023-02475-8. Epub 2023 Jan 20.

  PMID: 36670158 BACKGROUND

• Zhang, R., Huang, H., Lu, S., Chen, J., Pi, D., Dang, H., ... & Fu, Y. Q. (2024).

  BACKGROUND

• Park, S. J., Oh, S. H., & Jhang, W. K. (2023, November).

  BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nora AbdelHarithAmin

CONTACT

01024463473; nourahares27@gmail.com

Mahmoud AbdelFattah Ahmed

CONTACT

01003023766; mahmoudabdelfattah@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-09