ClinicalTrials.gg
Status unknownNCT03788460Updated Dec 27, 2018

Correlation Between PT and INR to Factor 7

An observational study in Epistaxis and ENT Disorder, sponsored by Laniado Hospital. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-12-27.

Sponsored by Laniado Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
60
Ages
Up to 18 Years
Sex
All
01

Study 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

Read the detailed description

Factor VII is one of the main components of the coagulation process. It belongs to the serine proteases and it dependents on vitamin K in order to function. Its primary function is to initiate the clotting process itself, along with tissue factor: Following a vascular endothelial injury, there is a response of vasoconstriction, the blood flow in contact with the subendothelial matrix, at that time, TF, a protein in the same matrix, binds to and activates the VII coagulation factor, then, FVIIa-TF complex begins the coagulation cascade, at the end of that cascade, fibrin is formed.

The factor VII gene is located on the long arm of chromosome 13, sized 12 kD, contains 12 axons that encode a protein composed of 406 amino acids, it's located at a distance of 2.8 kD from the gene of factor X.

More than 120 mutations have been found in factor VII gene to date, the association between genotype and phenotypes is unclear in most cases however. Seligsohn and his colleagues described one of the mutations in Factor VII, 5-Ser339Phe, which was found in three Tunisian families and caused a tendency to bleed through a mechanism of reduced factor X activation.

When it comes to Factor VII deficiency, the missing is never hermetic as such condition is not compatible with life as seen from work on knockout mice. Partially missing factor VII is the most common of all rare coagulation problems. Clinically, these are usually epistaxis, easy bruising, gum bleeding, muscle hematoma, hamarhtrosis, hematuria, postoperative bleeding, although there may also be conditions of life threatening blood in the nervous system and in the gastrointestinal tract. Except for increased menstruation that occurs in about 70% of the women with factor VII deficiency, there is no gender difference in symptoms.

Suspicion of Factor VII deficiency is usually done in the course of screening in family members with a known deficiency or on tests following an episode of bleeding, such as epistaxis or surgery in areas with a tendency to bleed (nose, throat or teeth) .

An abnormal PT test indicates a lack of factor VII. An elongated PTT test can suggest hemophilia A and B (missing factors VIII and IX, respectively), lack of factor XI, incomplete factor XII or von disease willebrand / VWF . The extension of PT also implies a deficiency in the factors X, V, II and fibrinogen, and the result is represented by a percentage relative to normal people.

The diagnosis of Factor VII deficiency is laboratory. The initial laboratory tests are PT, aPTT and platelet count, followed by a FVII coagulant activity test for prolonged PT states. In order to confirm the result, the FVII assay is performed again

Prothrombin time is typically analyzed by a laboratory technologist on an automated instrument at 37 °C. Blood is drawn into a test tube containing liquid sodium citrate, which acts as an anticoagulant by binding the calcium in a sample. The blood is mixed, then centrifuged to separate blood cells from plasma (as prothrombin time is most commonly measured using blood plasma). A sample of the plasma is extracted from the test tube and placed into a measuring test tube Next an excess of calcium is added to the test tube, thereby reversing the effects of citrate and enabling the blood to clot again. Finally, in order to activate the extrinsic / tissue factor clotting cascade pathway, tissue factor is added and the time the sample takes to clot is measured optically. The prothrombin ratio (INR) is the prothrombin time for a patient sample divided by the result for control plasma.

There are two types of Factor VII deficiency. The first is a quantitative with both a lack of FVII coagulant activity and with a low level of FVII antigen, the second one is qualitative with a low FVII coagulant activity but a normal level of FVII antigen. In fact, the examination of the antigen distinguishes between these two missing types, but does not predict the tendency to bleed, and it is not recommended to diagnose Factor VII deficiency on the basis of the antigen test. However, for known patients receiving a recombinant factor it can be useful.

There are no clear guidelines for the treatment of hereditary deficiency VII. Recombinant factor VII is a choice in many cases for both children and adults, but there are other treatment options as discussed in our study.

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.

02

Conditions studied

  • Epistaxis
  • ENT Disorder

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03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 12 observational studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

Laniado Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children with known factor VII deficiency

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Elongated PT value; Normal value;

Exclusion criteria

-

Exclusion Criteria:

Background medical conditions; Taking anticoagulants; Taking chronic medications;

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherno intervention

    no intervention

06

What researchers measure

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.

    Time frame: Study completion within 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2019; primary completion for Jan 2020, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2018
First posted
Dec 27, 2018
StartEst.
Jan 7, 2019
Primary completionEst.
Jan 2020
CompletionEst.
Jan 2020
Last update
Dec 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03788460
Lead sponsor
Laniado Hospital
Responsible party
Dr. Nechama Sharon (Head, Pediatric hemato-oncology unit, Laniado Hospital) — Principal investigator
First posted
Dec 27, 2018
Start date
Jan 7, 2019 (estimated)
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Dec 27, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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