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Correlation Between PT and INR to Factor 7

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ClinicalTrials.gov Identifier: NCT03788460
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Nechama Sharon, Laniado Hospital

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. 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. 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

Number of participants:

60 participants

Ages of participants:

0-18 years old

Gender of participants:

Both sexes

Inclusion criteria:

  1. A participant who is 0-18 years old
  2. A participant who is, except for bleeding tendency, healthy in general
  3. A participant who has elongated PT
  4. A participant who has normal PTT

Exclusion criteria:

  1. Background disease
  2. Use of medications
  3. Use of anti coagulation drugs

The duration of the study :

The study is of a retrospective type, we already have a number of subjects, we need more as to reach statistical significance, so the expectation is two to three months


Condition or disease Intervention/treatment
Epistaxis ENT Disorder Other: no intervention

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Retro-prospective Pediatric Data Collection Study of the Correlation Between PT and the Level of Coagulant Factor VII
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
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
no intervention




Primary Outcome Measures :
  1. Correlation between PT, INR and the level of coagulant factor VII [ Time Frame: Study completion within 2 years ]
    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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children with known factor VII deficiency
Criteria

Inclusion Criteria:

Elongated PT value; Normal PTT value;

-

Exclusion Criteria:

Background medical conditions; Taking anticoagulants; Taking chronic medications;

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788460


Contacts
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Contact: Nechama Sharon, MD +972-9-8604738 nsharon@laniado.org.il
Contact: Moshe Yana +972-9-8604717 myana@laniado.org.il

Sponsors and Collaborators
Laniado Hospital

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Responsible Party: Dr. Nechama Sharon, Head, Pediatric hemato-oncology unit, Laniado Hospital
ClinicalTrials.gov Identifier: NCT03788460     History of Changes
Other Study ID Numbers: 0062-18-LND
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms