Hemostatic Disorders on Intensive Care Patients.

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04179357
Collaborator
(none)
100
8

Study Details

Study Description

Brief Summary

  1. To assess the incidence of hemostatic disorders among ICU patients.

  2. To establish a relationship between supportive treatment and survival in patients with coagulopathy in ICU.

  3. To provide solutions that can help in reduction of the incidence of hemostatic disorders in ICU patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hemostasis is the physiological process that stops bleeding at the site of an injury while maintaining normal blood flow elsewhere in the circulation. Blood loss is stopped by formation of a hemostatic plug. The endothelium in blood vessels maintains an anticoagulant surface that serves to maintain blood in its fluid state, but if the blood vessel is damaged components of the subendothelial matrix are exposed to the blood. Several of these components activate the two main processes of hemostasis to initiate formation of a blood clot, composed primarily of platelets and fibrin.

    Many critically ill patients develop hemostatic abnormalities, ranging from isolated thrombocytopenia to complex defects, such as DIC. Coagulation abnormalities are commonly found in critically ill patients. Prompt and proper identification of the underlying cause of these coagulation abnormalities is required, since each coagulation disorder necessitates very different therapeutic management strategies.

    Management of coagulopathy The key basic management principle of all coagulopathies is that the decision to transfuse blood products should not be based on the results of coagulation tests alone, rather an individualized approach is warranted. It is imperative to synthesizes all the available clinical data and treat the underlying cause.

    In summary, hemostatic disorders are very common in the critically ill. Blood product support is frequently required, but there is only a very limited evidence-base to support its use. In many cases, no specific product support is required and the key management step is the treatment of the condition underlying the coagulopathy .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hemostatic Disorders Impact on Intensive Care Patients.
    Anticipated Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Sep 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Describe the Pattern of Homeostasis Disorders occur in Critical Care Unit in Assiut University [Baseline]

      Study the causes of either bleeding or thrombotic events in Critical care unit. Describe the pattern of the disease regarding age, sex and predisposing factors.

    Secondary Outcome Measures

    1. Correlate Supportive and Definitive Treatment and Outcomes of Patients with Homeostasis Disorder in ICU. [Baseline]

      Study the forms of transfusion ( e.g.packed red blood cells, Platelet , Fresh frozen plasma), anti bleeding measures (e.g. Tranexamic acid), anticoagulant and anti platelet drugs received by the patients and their outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Intensive care unit patients,aged more than 18 years .

    • Any Acquired bleeding disorders (platelet disorders; thrombocytopenia, acquired thrombocythemia and thrombocytosis, acquired coagulation defect, Thrombophilia ) Diagnosed in Critical care unit in Assiut university in one year time frame

    Exclusion Criteria:
    • Patient less than 18 years.

    • Patients with Inherited platelet defects ( Amegakaryoctye aplasia and Bernard Soulir syndrome)

    • Patients with Inherited coagulation defects (e.g.hemophilia , Von Willebrand disease and any inherited coagulation defect.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Fawzi Ibrahim Mansour, Resident Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04179357
    Other Study ID Numbers:
    • Hemostatic Disorders
    First Posted:
    Nov 27, 2019
    Last Update Posted:
    Nov 27, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 27, 2019