2015
A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children
Brousseau D, Scott J, Badaki-Makun O, Darbari D, Chumpitazi C, Airewele G, Ellison A, Smith-Whitley K, Mahajan P, Sarnaik S, Casper T, Cook L, Dean J, Leonard J, Hulbert M, Powell E, Liem R, Hickey R, Krishnamurti L, Hillery C, Nimmer M, Panepinto J, Network F. A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children. Blood 2015, 126: 1651-1657. PMID: 26232172, PMCID: PMC4591790, DOI: 10.1182/blood-2015-05-647107.Peer-Reviewed Original ResearchConceptsSickle cell pain crisisLength of stayPediatric Emergency Care Applied Research NetworkPain crisisIntravenous magnesiumOpioid useNormal saline placeboStudy drug infusionPlacebo-controlled trialHealth-related qualityQuality of lifeMorphine equivalentsStudy drugSaline placeboSecondary outcomesStandard therapyHemoglobin SSPediatric patientsPrimary outcomeDrug infusionPain relieversPlaceboStayChildren 4Group demographicsRandomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use
Telen M, Wun T, McCavit T, De Castro L, Krishnamurti L, Lanzkron S, Hsu L, Smith W, Rhee S, Magnani J, Thackray H. Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use. Blood 2015, 125: 2656-2664. PMID: 25733584, PMCID: PMC4408290, DOI: 10.1182/blood-2014-06-583351.Peer-Reviewed Original ResearchConceptsVaso-occlusive crisisSickle cell diseaseComposite primary end pointPrimary end pointPhase 2 studyEnd pointRandomized phase 2 studySCD vaso-occlusive crisisOpioid analgesic useSecondary end pointsActive treatment groupPhase 3 studyVaso-occlusive eventsAnalgesic usePlacebo groupProspective multicenterStudy drugAdverse eventsOpioid useSymptom reliefMedian timeSCD patientsCell diseaseTreatment groupsAnimal models
2013
A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease
Wun T, Soulieres D, Frelinger A, Krishnamurti L, Novelli E, Kutlar A, Ataga K, Knupp C, McMahon L, Strouse J, Zhou C, Heath L, Nwachuku C, Jakubowski J, Riesmeyer J, Winters K. A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. Journal Of Hematology & Oncology 2013, 6: 17. PMID: 23414938, PMCID: PMC3585853, DOI: 10.1186/1756-8722-6-17.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAnemia, Sickle CellBiomarkers, TumorCell Adhesion MoleculesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMicrofilament ProteinsMiddle AgedPainPhosphoproteinsPiperazinesPlatelet ActivationPlatelet Aggregation InhibitorsPrasugrel HydrochloridePrognosisPurinergic P2Y Receptor AntagonistsThiophenesYoung AdultConceptsSickle cell diseaseHemorrhagic eventsAdult patientsAntiplatelet agentsSCD patientsCell diseaseP-selectinMedical interventionsMulticenter phase 2 studyPlatelet surface P-selectinMethodsThe primary endpointPlatelet activation biomarkersSafety of prasugrelSerious hemorrhagic eventsPlacebo-controlled studyPhase 2 studyVivo platelet activationSoluble P-selectinSurface P-selectinThienopyridine antiplatelet agentPain ratePrasugrel armPrimary endpointActivation biomarkersStudy arms
2011
Hospitalization for pain in patients with sickle cell disease treated with sildenafil for elevated TRV and low exercise capacity
Machado R, Barst R, Yovetich N, Hassell K, Kato G, Gordeuk V, Gibbs J, Little J, Schraufnagel D, Krishnamurti L, Girgis R, Morris C, Rosenzweig E, Badesch D, Lanzkron S, Onyekwere O, Castro O, Sachdev V, Waclawiw M, Woolson R, Goldsmith J, Gladwin M. Hospitalization for pain in patients with sickle cell disease treated with sildenafil for elevated TRV and low exercise capacity. Blood 2011, 118: 855-864. PMID: 21527519, PMCID: PMC3148167, DOI: 10.1182/blood-2010-09-306167.Peer-Reviewed Original ResearchConceptsTricuspid regurgitation velocitySickle cell diseaseLower exercise capacityExercise capacityCell diseaseN-terminal pro-brain natriuretic peptideElevated tricuspid regurgitation velocityPro-brain natriuretic peptideSerious adverse eventsPulmonary arterial hypertensionSildenafil trialArterial hypertensionAdverse eventsWalk distanceDoppler echocardiographySCD patientsHospitalization ratesNatriuretic peptidePatientsSildenafilPredominant causePainHospitalizationTreatment effectsDiseaseNitric Oxide for Inhalation in the Acute Treatment of Sickle Cell Pain Crisis: A Randomized Controlled Trial
Gladwin M, Kato G, Weiner D, Onyekwere O, Dampier C, Hsu L, Hagar R, Howard T, Nuss R, Okam M, Tremonti C, Berman B, Villella A, Krishnamurti L, Lanzkron S, Castro O, Gordeuk V, Coles W, Peters-Lawrence M, Nichols J, Hall M, Hildesheim M, Blackwelder W, Baldassarre J, Casella J, Investigators F. Nitric Oxide for Inhalation in the Acute Treatment of Sickle Cell Pain Crisis: A Randomized Controlled Trial. JAMA 2011, 305: 893-902. PMID: 21364138, PMCID: PMC3403835, DOI: 10.1001/jama.2011.235.Peer-Reviewed Original ResearchConceptsVaso-occlusive pain crisesSickle cell diseaseVisual analog pain scale scoreAcute chest syndromePrimary end pointPain scale scoresNitric oxideChest syndromePain crisisPainful crisesScale scoreSickle cell pain crisisSmall placebo-controlled trialsPlacebo-controlled clinical trialEnd pointNitric oxide gasCumulative opioid usageParenteral opioid useWhole blood nitritePlacebo-controlled trialSerious adverse eventsLength of hospitalizationSecondary outcome measuresEvidence of efficacyOpioid usage