NCT04179357

Brief Summary

  1. 1.To assess the incidence of hemostatic disorders among ICU patients.
  2. 2.To establish a relationship between supportive treatment and survival in patients with coagulopathy in ICU.
  3. 3.To provide solutions that can help in reduction of the incidence of hemostatic disorders in ICU patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

September 24, 2019

Last Update Submit

November 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Correlate Supportive and Definitive Treatment and Outcomes of Patients with Homeostasis Disorder in ICU.

    Baseline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All cases who will be admitted at the intensive care units at Assiut university Hospital through 1 year duration .

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25440406BACKGROUND
  • 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.

    PMID: 24571757BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Mohamed Fawzi Ibrahim, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

September 24, 2019

First Posted

November 27, 2019

Study Start

January 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 27, 2019

Record last verified: 2019-11