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Hemostatic Disorders on Intensive Care Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179357
Recruitment Status : Unknown
Verified November 2019 by Mohamed Fawzi Ibrahim Mansour, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Fawzi Ibrahim Mansour, Assiut University

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
Hemostatic Disorder

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 .

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemostatic Disorders Impact on Intensive Care Patients.
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Describe the Pattern of Homeostasis Disorders occur in Critical Care Unit in Assiut University [ Time Frame: 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. [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All cases who will be admitted at the intensive care units at Assiut university Hospital through 1 year duration .
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179357


Contacts
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Contact: Mohamed Fawzi Ibrahim, Master +201099028136 muhammadfawzi10@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Mohamed Fawzi Ibrahim Mansour, Resident Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04179357    
Other Study ID Numbers: Hemostatic Disorders
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases