Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department
NCT ID: NCT02386657
Last Updated: 2016-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2012-11-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Satisfaction questionnaire to be filled in
Biological parameters
Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).
Pain management
Validated pain scale questionnaire to be filled in
Interventions
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Satisfaction
Satisfaction questionnaire to be filled in
Biological parameters
Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).
Pain management
Validated pain scale questionnaire to be filled in
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Brugmann University Hospital
OTHER
Responsible Party
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Andre Efira
Head of Clinic
Principal Investigators
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Marie-Agnès Azerad, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann
Locations
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CHU Brugmann
Brussels, , Belgium
Countries
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References
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Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.
Solomon LR. Treatment and prevention of pain due to vaso-occlusive crises in adults with sickle cell disease: an educational void. Blood. 2008 Feb 1;111(3):997-1003. doi: 10.1182/blood-2007-07-089144. Epub 2007 Oct 16.
Brookoff D, Polomano R. Treating sickle cell pain like cancer pain. Ann Intern Med. 1992 Mar 1;116(5):364-8. doi: 10.7326/0003-4819-116-5-364.
Payne R. Sickle cell anemia and pain: will data prevail over beliefs? Ann Emerg Med. 2009 May;53(5):596-7. doi: 10.1016/j.annemergmed.2008.10.022. No abstract available.
Zempsky WT. Treatment of sickle cell pain: fostering trust and justice. JAMA. 2009 Dec 9;302(22):2479-80. doi: 10.1001/jama.2009.1811. No abstract available.
Tanabe P, Artz N, Mark Courtney D, Martinovich Z, Weiss KB, Zvirbulis E, Hafner JW. Adult emergency department patients with sickle cell pain crisis: a learning collaborative model to improve analgesic management. Acad Emerg Med. 2010 Apr;17(4):399-407. doi: 10.1111/j.1553-2712.2010.00693.x.
Tanabe P, Hafner JW, Martinovich Z, Artz N. Adult emergency department patients with sickle cell pain crisis: results from a quality improvement learning collaborative model to improve analgesic management. Acad Emerg Med. 2012 Apr;19(4):430-8. doi: 10.1111/j.1553-2712.2012.01330.x.
Anie KA, Grocott H, White L, Dzingina M, Rogers G, Cho G. Patient self-assessment of hospital pain, mood and health-related quality of life in adults with sickle cell disease. BMJ Open. 2012 Jul 2;2(4):e001274. doi: 10.1136/bmjopen-2012-001274. Print 2012.
Stankovic Stojanovic K, Steichen O, Lefevre G, Bachmeyer C, Avellino V, Grateau G, Girot R, Lionnet F. High lactate dehydrogenase levels at admission for painful vaso-occlusive crisis is associated with severe outcome in adult SCD patients. Clin Biochem. 2012 Dec;45(18):1578-82. doi: 10.1016/j.clinbiochem.2012.07.114. Epub 2012 Aug 8.
Ataga KI, Brittain JE, Desai P, May R, Jones S, Delaney J, Strayhorn D, Hinderliter A, Key NS. Association of coagulation activation with clinical complications in sickle cell disease. PLoS One. 2012;7(1):e29786. doi: 10.1371/journal.pone.0029786. Epub 2012 Jan 11.
Rees DC, Gibson JS. Biomarkers in sickle cell disease. Br J Haematol. 2012 Feb;156(4):433-45. doi: 10.1111/j.1365-2141.2011.08961.x. Epub 2011 Nov 28.
Schnog JB, Teerlink T, van der Dijs FP, Duits AJ, Muskiet FA; CURAMA Study Group. Plasma levels of asymmetric dimethylarginine (ADMA), an endogenous nitric oxide synthase inhibitor, are elevated in sickle cell disease. Ann Hematol. 2005 May;84(5):282-6. doi: 10.1007/s00277-004-0983-3. Epub 2004 Dec 14.
Nur E, Brandjes DP, Teerlink T, Otten HM, Oude Elferink RP, Muskiet F, Evers LM, ten Cate H, Biemond BJ, Duits AJ, Schnog JJ; CURAMA study group. N-acetylcysteine reduces oxidative stress in sickle cell patients. Ann Hematol. 2012 Jul;91(7):1097-105. doi: 10.1007/s00277-011-1404-z. Epub 2012 Feb 10.
Wayenberg JL, Ransy V, Vermeylen D, Damis E, Bottari SP. Nitrated plasma albumin as a marker of nitrative stress and neonatal encephalopathy in perinatal asphyxia. Free Radic Biol Med. 2009 Oct 1;47(7):975-82. doi: 10.1016/j.freeradbiomed.2009.07.003. Epub 2009 Jul 8.
Other Identifiers
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CHUB-Edu
Identifier Type: -
Identifier Source: org_study_id
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