Correlation Between PT and INR to Factor 7

NCT03788460 | Unknown

• 1 other identifier: 0062-18-LND
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our study: Given the large number of coagulability tests done before a number of surgeries, specially otolaryngology procedures, such as tonsillectomy and adenoidectomy, as well as a part of epistaxis workup, prothrombin time (PT) and partial thromboplastin time (PTT) were checked, and it was found that in some people there is an isolated elongated PT, a low level of factor VII was found in these people. The purpose of the current study is to find a correlation between the value of PT\\INR and the level of factor VII, we tried to do so by a retro-prospective study on patients known to have a factor VII deficiency at Laniado hospital, such a correlation could make both the diagnosis and the management of people with factor VII deficiency easier and more accessible. The study levels:

1. 1.Data collection : On the children's population who are known for their lack of Factor VII, we will check PT levels, we will concentrate the data in the table, along with personal information such as age and gender
2. 2.Data Processing : We will try to conduct a statistical relationship between the PT values and Factor VII levels, to look for statistical significance, we will try to find a model for predicting the level of factor VII based on PT
3. 3.A participant who is 0-18 years old
4. 4.A participant who is, except for bleeding tendency, healthy in general
5. 5.A participant who has elongated PT
6. 6.A participant who has normal PTT
7. 7.Background disease
8. 8.Use of medications
9. 9.Use of anti coagulation drugs

Conditions

Epistaxis; ENT Disorder

Outcome Measures

Primary Outcomes (1)

• Correlation between PT, INR and the level of coagulant factor VII

  correlation between PT / INR value and percent of factor VII through a retro-prospective study of patients who are known to have factor VII deficiency. This correlation is expected to facilitate diagnostic and monitoring procedures for patients with factor VII deficiency. The clinical value of this study is to facilitate diagnosis and treatment in patients with Factor VII defiency.

  Study completion within 2 years

Study Arms (1)

childrens population with lack of Factor VI

We will check PT levels, we will concentrate the data in the table, along with personal information such as age and gender. We will try to conduct a statistical relationship between the PT values and Factor VII levels, to look for statistical significance, we will try to find a model for predicting the level of factor VII based on PT

Other: no intervention

Interventions

no intervention OTHER

no intervention

childrens population with lack of Factor VI

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with known factor VII deficiency

You may qualify if:

• Elongated PT value; Normal PTT value;

You may not qualify if:

• Background medical conditions; Taking anticoagulants; Taking chronic medications;

Sponsors & Collaborators

• Laniado Hospital: lead

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Nechama Sharon, MD

CONTACT

+972-9-8604738; nsharon@laniado.org.il

Moshe Yana

CONTACT

+972-9-8604717; myana@laniado.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pediatric hemato-oncology unit

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 27, 2018
• Study Start: January 7, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share