Hemostatic Disorders on Intensive Care Patients.

NCT ID: NCT04179357

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-09-30

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.

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 .

Conditions

Hemostatic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fawzi Ibrahim Mansour

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Fawzi Ibrahim, Master

Role: CONTACT

muhammadfawzi10@gmail.com

+201099028136

References

Retter A, Barrett NA. The management of abnormal haemostasis in the ICU. Anaesthesia. 2015 Jan;70 Suppl 1:121-7, e40-1. doi: 10.1111/anae.12908.

Reference Type: BACKGROUND

PMID: 25440406 (View on PubMed)

Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014 Feb 27;370(9):847-59. doi: 10.1056/NEJMra1208626. No abstract available.

Reference Type: BACKGROUND

PMID: 24571757 (View on PubMed)

Other Identifiers

Hemostatic Disorders

Identifier Type: -

Identifier Source: org_study_id