Ignite Creation Date:
2024-05-06 @ 9:39 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03032055
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2015-11-18
Brief Title:
Validation of a Predictive Score of Acute Chest Syndrome
Sponsor:
Soutien aux Actions contre les Maladies du Globule Rouge
Organization:
Soutien aux Actions contre les Maladies du Globule Rouge
Study Overview
Official Title:
Validation of a Predictive Score of Acute Chest Syndrome
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Presev2
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
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 eg limbs ribs sternum head skull spine andor 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 andor leucocytes counts urea mmolL and Categorical pain score
The Score is adjusted with Hydroxyurea treatment YesNo and Hb level gdL Plasmodium falciparum test will be performed only in Africa Hemoculture if fever 38C 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
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 eg limbs ribs sternum head skull spine andor 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 andor leucocytes counts urea mmolL and Categorical pain score
The Score is adjusted with Hydroxyurea treatment YesNo and Hb level gdL Plasmodium falciparum test will be performed only in Africa Hemoculture if fever 38C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None