Validation of a Predictive Score of Acute Chest Syndrome

Acute Chest Syndrome Clinical Trial

— Presev2  

Official title:

Validation of a Predictive Score of Acute Chest Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03032055
• Other study ID #: Presev 2 IRB 00003835
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Soutien aux Actions contre les Maladies du Globule Rouge
• Contact: DJOUMAD Sabrina, Master's
• Phone: 33 (1) 49812441
• Email: sabrina.djoumad[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Chest Syndrome
• Syndrome
• Vaso Occlusive Crisis

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (3)

Lead Sponsor	Collaborator
Soutien aux Actions contre les Maladies du Globule Rouge	ADDMEDICA SASA, Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure of Validation of a Predictive Score of Acute Chest Syndrome	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	2 years
Secondary	Secondary Outcome Measures: Validation of a Predictive Score of Acute Chest Syndrome	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	2 years