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Trials / Completed

CompletedNCT02386657

Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department

Status
Completed
Phase
Study type
Observational
Enrollment
104 (actual)
Sponsor
Brugmann University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSatisfactionSatisfaction questionnaire to be filled in
OTHERBiological parametersMeasure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).
OTHERPain managementValidated pain scale questionnaire to be filled in

Timeline

Start date
2012-11-01
Primary completion
2015-02-01
Completion
2016-06-01
First posted
2015-03-12
Last updated
2016-07-21

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02386657. Inclusion in this directory is not an endorsement.