Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department
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|ClinicalTrials.gov Identifier: NCT02386657|
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : July 21, 2016
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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.
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease||Other: Satisfaction Other: Biological parameters Other: Pain management|
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||June 2016|
Emergency admitted sickle cell disease patients
Sickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Satisfaction questionnaire to be filled in
Other: Biological parameters
Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).
Other: Pain management
Validated pain scale questionnaire to be filled in
- EVA pain scale [ Time Frame: 48 hours ]The pain will be evaluated using the EVA scale (Visual Analogic scale) by the patient himself and by the nursing staff (hetero-anamnesis). Time frames will be: at admission within the emergency department, 1 hour after admission, 3h after admission, 6 hours after admission and, if the pain did not disappear by then, every 6 hours until the pain disappears.
- Satisfaction questionnaire [ Time Frame: 10 days ]Satisfaction of the patient regarding the management of his/her pain management.
- Morphine amount [ Time Frame: 10 days ]Morphine amount administrated within the Emergency Department and during hospitalization length.
- Hospitalisation length [ Time Frame: 10 days ]Time needed being hospitalized in order to control the pain level after the initial episode.
- Standard biological parameters [ Time Frame: at hospital emergency service admission ]Dosage of the standard biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and the nitrous albumin levels (PNA) at hospital admission.
- Standard biological parameters [ Time Frame: 10 days ]Dosage of the standard biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and the nitrous albumin levels (PNA) at the end of hospitalisation.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- Patients not being able to sign the informed consent form or fill in the analogic visual questionnaire (EVA)
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): NCT02386657
|Brussels, Belgium, 1020|
|Principal Investigator:||Marie-Agnès Azerad, MD||CHU Brugmann|
|Responsible Party:||Andre Efira, Head of Clinic, Brugmann University Hospital|
|Other Study ID Numbers:||
|First Posted:||March 12, 2015 Key Record Dates|
|Last Update Posted:||July 21, 2016|
|Last Verified:||July 2016|
Sickle Cell Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn