Shock, SepticNCT06581172
Significance of Disseminated Intravascular Coagulation Score in Mortality for Children With Shock
An observational study of Shock, Septic, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Shock, Septic
- What is being tested?
- D_dimer
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
Study population: Children with shock and DIC
Who may be able to join
- All Children with shock and DIC will developed during the period from 1-1-2025 to 31-12-2025
Who cannot join
- Any shock not complicated with DIC
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the detailed description
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 .
- Conditions
- Shock, Septic
- Being tested
- D_dimer
- Keywords
- DIC score
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D_dimerDiagnostic test
DIC score including FDPs,D_dimer
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
Sample size
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%.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Abdel Harith Amin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581172
- Sponsor's protocol ID
- DIC
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38299935Infante, J. B., Esteves, G. V., Raposo, J., & de Lacerda, J. F. (2024)
Kim, T. W., Ko, R. E., Choi, K. H., Chung, C. R., Cho, Y. H., & Yang, J. H. (2024)
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.
PubMed 38452037Rashad, A. B., Habib, M. S., Saleh, N. Y., & Abo El Fotoh, W. M. (2023)
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.
PubMed 36670158Zhang, R., Huang, H., Lu, S., Chen, J., Pi, D., Dang, H., ... & Fu, Y. Q. (2024).
Park, S. J., Oh, S. H., & Jhang, W. K. (2023, November).
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Disseminated Intravascular Coagulation Score in Mortality for Children With Shock
- ClinicalTrials.gov ID
- NCT06581172
- Acronym / sponsor ID
- DIC
- Conditions
- Shock, Septic
- Keywords
- DIC score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with shock and DIC
Key inclusion criteria (1 listed)
- All Children with shock and DIC will developed during the period from 1-1-2025 to 31-12-2025
Key exclusion criteria (1 listed)
- Any shock not complicated with DIC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D_dimerDIC score including FDPs,D_dimer | Diagnostic test | – |
Primary outcome
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 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
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.
1 secondary outcome
Sample size
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 38299935Chanthong 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.
- BackgroundInfante, J. B., Esteves, G. V., Raposo, J., & de Lacerda, J. F. (2024)
- BackgroundKim, T. W., Ko, R. E., Choi, K. H., Chung, C. R., Cho, Y. H., & Yang, J. H. (2024)
- Background: PubMed 38452037Zafar 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.
- BackgroundRashad, A. B., Habib, M. S., Saleh, N. Y., & Abo El Fotoh, W. M. (2023)
- Background: PubMed 36670158Songthawee 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.
- BackgroundZhang, R., Huang, H., Lu, S., Chen, J., Pi, D., Dang, H., ... & Fu, Y. Q. (2024).
- BackgroundPark, S. J., Oh, S. H., & Jhang, W. K. (2023, November).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, Septic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora AbdelHarithAmin (01024463473, nourahares27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581172, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.