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Validation of a Predictive Score of Acute Chest Syndrome (Presev2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032055
Recruitment Status : Unknown
Verified January 2017 by Soutien aux Actions contre les Maladies du Globule Rouge.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
ADDMEDICA SASA
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Soutien aux Actions contre les Maladies du Globule Rouge

Brief Summary:

Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is the first cause of death, particularly when complicated by an acute chest syndrome (ACS).

The PRESEV score could help the physicians to better manage VOC and could be used for future therapeutic trials. This predictive score of secondary ACS has to be validated in a multicenter international study.


Condition or disease
Vaso Occlusive Crisis Acute Chest Syndrome

Detailed Description:

International multicentre prospective observational study.

Prediction of an ACS within 15 days after admission by the PRESEV2 score at arrival.

Validation of a Predictive Score of Acute Chest Syndrome (Presev2) associates a categorical pain score of the spine /or pelvis and 3 biological parameters: Reticulocytes, Leucocytes and Hemoglobin.

ACS is defined by crepitant or bronchial breathing or the association of new radiologic infiltrate and chest pain

Inclusion criteria:

  • Children (>2 years) and adults
  • Male and Female
  • Homozygous SCD patients
  • The patient can only be included once
  • VOC admitted at the emergency unit (a severe VOC is defined as pain or tenderness affecting at least one part of the body (e.g. limbs, ribs, sternum, head (skull), spine and/or pelvis) that required hospitalization and opioids (level 3), and is not attributable to other causes.
  • Patient has health care insurance (in Europe)
  • Written consent given after being informed of the purpose, progress and potential risks

Exclusion criteria:

  • No inaugural Acute Chest Syndrome
  • Homeless patients
  • Deprived of their liberty by a court or administrative order or under guardianship
  • Unable to understand the purpose and conditions of carrying out the study, unable to give consent

STUDY SCHEDULE Screening and inclusion once patients are admitted at the accident and emergency department or medical day unit.

Inclusion visit (day 1) Once admitted at the accident and emergency department, the patient will be informed about the protocol and asked to participate in the study. Informed consent will be obtained according to local regulations by signing the informed consent form. The inclusion and non-inclusion criteria will be verified.

Demographic data, current and previous treatments taken within one month, and medical history will be recorded.

The following parameters of the score will be collected:

Reticulocytes and/or leucocytes counts, urea (mmol/L) and Categorical pain score.

The Score is adjusted with Hydroxyurea treatment (Yes/No) and Hb level (g/dL). Plasmodium falciparum test will be performed only in Africa. Hemoculture if fever (>38°C) is recorded within the 2 first days after admission.

Temperature, Blood pressure, Oxygen saturation, Respiratory rate, Visual analogue score will be recorded.

STUDY DURATION Inclusion period: 2 years Per patient: 15 days Total duration of the study: 2 years

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Predictive Score of Acute Chest Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Group/Cohort
VOC

Patients who won't develop a secondary Acute chest syndrome during a vaso occlusive crisis within 15 days after admission.

Secondary Acute chest syndrome is defined by a new auscultatory abnormality (crepitation or bronchial breathing) OR the association of a new radiologic infiltrate and chest pain or decreased breath sounds .

A vaso-occlusive crisis is a common painful complication of sickle cell anemia in adolescents and adults. It is a form of sickle cell crisis. Sickle cell anemia - most common in those of African, Hispanic, and Mediterranean origin - leads to sickle cell crisis when the circulation of blood vessels is obstructed by sickled red blood cells, causing ischemic injuries.

2°ACS

Patients who will develop a secondary acute chest syndrome during a vaso occlusive crisis within 15 days after admission.

Secondary Acute chest syndrome is defined by a new auscultatory abnormality (crepitation or bronchial breathing) OR the association of a new radiologic infiltrate AND chest pain or decreased breath sounds .

A vaso-occlusive crisis is a common painful complication of sickle cell anemia in adolescents and adults.It is a form of sickle cell crisis. Sickle cell anemia - most common in those of African, Hispanic, and Mediterranean origin - leads to sickle cell crisis when the circulation of blood vessels is obstructed by sickled red blood cells, causing ischemic injuries.




Primary Outcome Measures :
  1. Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome [ Time Frame: 2 years ]
    The primary outcome mesure is the occurrence of an ACS defined by crepitant or bronchial breathing or the association of new radiologic infiltrats and chest pain during the first 15 days of hospitalization for Vaso Occlusive Crisis


Secondary Outcome Measures :
  1. Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome [ Time Frame: 2 years ]

    Association of the PRESEV 2 score with the following parameters collected for each patient:

    • The number of days of hospitalization
    • Blood transfusion requirement
    • The number of hospitalization in intensive care unit
    • Death


Biospecimen Retention:   Samples With DNA
serum and DNA in Africa


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children (>2 years) and adults

  • Male and Female
  • Homozygous SCD patients
  • VOC admitted at the emergency unit (a severe VOC is defined as pain or tenderness affecting at least one part of the body (e.g. limbs, ribs, sternum, head (skull), spine and/or pelvis) that required hospitalization and opioids (level 3), and is not attributable to other causes
Criteria

Inclusion Criteria:

  • Inclusion criteria:
  • Children (>2 years) and adults
  • Male and Female
  • Homozygous SCD patients
  • VOC admitted at the emergency unit (a severe VOC is defined as pain or tenderness affecting at least one part of the body (e.g. limbs, ribs, sternum, head (skull), spine and/or pelvis) that required hospitalization and opioids (level 3), and is not attributable to other causes.
  • Patient has health care insurance (in Europe)
  • Written consent given after being informed of the purpose, progress and potential risks

Exclusion criteria:

  • No inaugural Acute Chest Syndrome
  • Homeless patients
  • Deprived of their liberty by a court or administrative order or under guardianship
  • Unable to understand the purpose and conditions of carrying out the study, unable to give consent

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): NCT03032055


Contacts
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Contact: DJOUMAD Sabrina, Master's 33 (1) 49812441 sabrina.djoumad@aphp.fr
Contact: BERKENOU Jugurtha, Master's 33 (1) 49814414 jugurtha.berkenou@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94000
Contact: Pablo BARTOLUCCI, Professor    33 (1) 49817406    pablo.bartolucci@aphp.fr   
Sponsors and Collaborators
Soutien aux Actions contre les Maladies du Globule Rouge
ADDMEDICA SASA
Pierre Fabre Laboratories
Investigators
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Principal Investigator: BARTOLUCCI Pablo, MD PhD, Pr APHP, UPEC, INSERM
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Responsible Party: Soutien aux Actions contre les Maladies du Globule Rouge
ClinicalTrials.gov Identifier: NCT03032055    
Other Study ID Numbers: Presev 2 IRB 00003835
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Soutien aux Actions contre les Maladies du Globule Rouge:
sickle cell desease
vaso occlusive crisis
acute chest syndrome
Validation of predictif score of acute chest syndrome
Additional relevant MeSH terms:
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Acute Chest Syndrome
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn