Clinical trial NCT03032055: Validation of a Predictive Score of Acute Chest Syndrome
Official title: Validation of a Predictive Score of Acute Chest Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaso Occlusive Crisis
Acute Chest Syndrome
Keywords: sickle cell desease
vaso occlusive crisis
acute chest syndrome
Validation of predictif score of acute chest syndrome
Lead sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
Sponsor class: OTHER
Collaborators: name: Theravia
name: Pierre Fabre Laboratories
First posted: 2017-01-26
Enrollment: 800
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility 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

Primary outcomes:
measure: Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome
timeFrame: 2 years
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: APHP, UPEC, INSERM
name: BARTOLUCCI Pablo, MD PhD, Pr
role: PRINCIPAL_INVESTIGATOR
References: