Hemostatic DisorderNCT04179357
Hemostatic Disorders on Intensive Care Patients.
An observational study of Hemostatic Disorder, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemostatic Disorder
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All cases who will be admitted at the intensive care units at Assiut university Hospital through 1 year duration .
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hemostatic Disorders Impact on Intensive Care Patients.
- To assess the incidence of hemostatic disorders among ICU patients.
- To establish a relationship between supportive treatment and survival in patients with coagulopathy in ICU.
- To provide solutions that can help in reduction of the incidence of hemostatic disorders in ICU patients.
Read the 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
- Medical subject headings
- Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the Pattern of Homeostasis Disorders occur in Critical Care Unit in Assiut University
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.
Measured: Baseline
Secondary outcomes (1)
Correlate Supportive and Definitive Treatment and Outcomes of Patients with Homeostasis Disorder in ICU.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemostatic DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzi Ibrahim Mansour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179357
- Sponsor's protocol ID
- Hemostatic Disorders
- Status last verified
- Nov 2019
- First submitted
- 24 Sep 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25440406Hunt 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.
PubMed 24571757
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Disorders Impact on Intensive Care Patients.
- ClinicalTrials.gov ID
- NCT04179357
- Acronym / sponsor ID
- Hemostatic Disorders
- Conditions
- Hemostatic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the incidence of hemostatic disorders among ICU patients.
- To establish a relationship between supportive treatment and survival in patients with coagulopathy in ICU.
- 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All cases who will be admitted at the intensive care units at Assiut university Hospital through 1 year duration .
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlate Supportive and Definitive Treatment and Outcomes of Patients with Homeostasis Disorder in ICU.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Background: PubMed 25440406Retter 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.
- Background: PubMed 24571757Hunt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostatic Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fawzi Ibrahim, Master (+201099028136, muhammadfawzi10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the Pattern of Homeostasis Disorders occur in Critical Care Unit in Assiut University (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.