Clinical trial NCT02386657: Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department
Official title: Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Vaso-occlusive crisis
Emergency management
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sickle Cell Disease patients, entering the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.

Brief summary: Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. The age average of the patients is below 30. The hospital developed a close collaboration with the Queen Fabiola Kids University Hospital to optimize the transition of young sickle cell patients from the pediatric to the adult network.

The emergency care of sickle cell patients remains a source of worry. Even with a correct treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The crisis are more frequent with poor compliance to the treatments.

There are several obstacles to the rapid and optimal management of these patients:

* fear of causing addiction to heavy pain releaf products (high dosis of morphine)
* lack of biological parameters for the determination of the crisis severity.

The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was recently stressed while activation of the coagulation, translated by the elevation of various parameters including the rate of DD dimers, seemed associated with clinical complications. The deleterious role of increased oxidative stress has also been recently demonstrated in patients with sickle cell disease, opening new therapeutic avenues.

This study aims to prospectively evaluate the management of sickle cell patients being admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction of the patients will be measured.

The investigators will also evaluate the predictive value of several routine biological parameters regarding the severity of the crisis, including the values of nitrous albumin (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the team of Dr Wayenberg and Pr Bottari in Grenoble.


Eligibility criteria: Inclusion Criteria:

* Any sickle cell disease patient being admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis, having signed the informed consent form and being able to fill in the analogic visual questionnaire (EVA).

Exclusion Criteria:

* Patients not being able to sign the informed consent form or fill in the analogic visual questionnaire (EVA)

Primary outcomes:
measure: EVA pain scale
timeFrame: 48 hours
Secondary outcomes:
measure: Satisfaction questionnaire
timeFrame: 10 days
measure: Morphine amount
timeFrame: 10 days
measure: Hospitalisation length
timeFrame: 10 days
measure: Standard biological parameters
timeFrame: at hospital emergency service admission
measure: Standard biological parameters
timeFrame: 10 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Marie-Agnès Azerad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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