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Not yet recruitingNCT06586346Updated Sep 19, 2024

Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit

An observational study in Coagulopathy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
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Study summary

In intensive care units , sepsis remains one of the common causes of mortality and morbidity . The average hospital length of stay for sepsis is twice as long as any other fatal condition . Furthermore, sepsis survivors are at an increased risk of death or a reduced health related quality of life even after discharge from the hospital . Sepsis induces multiple and complex derangements in many systems including the coagulation cascade. The vast majority of septic patients present with hemostatic abnormalities ranging from subclinical coagulopathy to fulminant disseminated intravascular coagulation . During the initial stages of infection coagulation operates as a natural defense mechanism attempting to confine the responsible pathogen and prevent its spread into systematic circulation. However in advanced and severe infections as in sepsis, mass inflammatory cytokine production and release into the circulation lead to significantly deranged hemostatic balance . The coagulation process is activated while anticoagulant mechanisms including fibrinolysis and anticoagulant factors are suppressed. Consequently septic patients are prone to a prothrombotic state through four main mechanisms extrinsic pathway activation, cytokine induced coagulation amplification, anticoagulant pathways suppression, and fibrinolysis impairment .

Read the detailed description

Sepsis is defined as a life-threatening syndrome associated with physiological, pathological and biological abnormalities caused by a dysregulated host response to infections . Globally, there are ∼48.9 million sepsis cases, leading to 11 million deaths annually .

In intensive care units , sepsis remains one of the common causes of mortality and morbidity . The average hospital length of stay for sepsis is twice as long as any other fatal condition and the in-hospital mortality remains as high as 20% . Furthermore, sepsis survivors are at an increased risk of death or a reduced health-related quality of life even after discharge from the hospital .

Sepsis induces multiple and complex derangements in many systems, including the coagulation cascade. The vast majority of septic patients present with hemostatic abnormalities, ranging from subclinical coagulopathy to fulminant disseminated intravascular coagulation (DIC) . During the initial stages of infection, coagulation operates as a natural defense mechanism, attempting to confine the responsible pathogen and prevent its spread into systematic circulation. However, in advanced and severe infections, as in sepsis, mass inflammatory cytokine production and release into the circulation lead to significantly deranged hemostatic balance . The coagulation process is activated, while anticoagulant mechanisms, including fibrinolysis and anticoagulant factors, are suppressed. Consequently, septic patients are prone to a prothrombotic state through 4 main mechanisms: extrinsic pathway activation, cytokine-induced coagulation amplification, anticoagulant pathways suppression, and fibrinolysis

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Conditions studied

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In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 229 observational studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with 18 years of ago or older who will be admitted to critical care unit with sepsis during period between october 2024 and october 2026 ,they will divided into two groups according to development of sepsis induced coagulopathy

Inclusion criteria

  • Patients with 18 years of ago or older who will be admitted to critical care unit with sepsis during period between october 2024 and october 2026.

Exclusion criteria

Exclusion Criteria:

  • patients under tge age of 18patients with end organ diseases
  • pregnant woman
  • patient with coagulation disorder
  • patient using anticoagulant drugs
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Assess frequency and severity of sepsis induced coagulopathy in critical care unit

    Assess frequency and severity of sepsis induced coagulopathy in critical care unit

    Time frame: 10/9/2024 - 1/10/2026

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 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
NCT06586346
Lead sponsor
Assiut University
Responsible party
Amira ahmed mohamed samony (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 10, 2024 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Amira Ahmed
Contact
amira.16266014@med.aun.edu.eg
+201061223591
Mahmoud Ali, Pro
Contact
mahmoudashri@med.aun.edu.eg
01006901937
Dina Ali, Dr
study director · Assiut University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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