Hemostatic Disorders on Intensive Care Patients.

• ClinicalTrials.gov Identifier: NCT04179357
• Recruitment Status: Unknown
• First Posted: November 27, 2019
• Last Update Posted: November 27, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed Fawzi Ibrahim Mansour, Assiut University

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
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 .

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Assiut University

More Information

Publications:

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. Review.

Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014 Feb 27;370(9):847-59. doi: 10.1056/NEJMra1208626. Review.

• 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
• Last Update Posted: November 27, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hemostatic Disorders; Blood Coagulation Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases