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
2014
A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children
Brousseau D, Scott J, Badaki O, Darbari D, Chumpitazi C, Airewele G, Ellison A, Smith-Whitley K, Mahajan P, Sarnaik S, Casper T, Cook L, Dean M, Leonard J, Hulbert M, Powell E, Liem R, Hickey R, Krishnamurti L, Hillery C, Panepinto J. A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children. Blood 2014, 124: 88. DOI: 10.1182/blood.v124.21.88.88.Peer-Reviewed Original ResearchSickle cell pain crisisLength of stayAcute chest syndromePediatric Emergency Care Applied Research NetworkQuality of lifePain crisisPediatric emergency medicine physiciansOpioid useIntravenous magnesiumSickle cell diseaseEmergency medicine physiciansMorphine equivalentsPlacebo groupStudy drugAdverse eventsDrug infusionCell diseaseMedicine physiciansHistory of ACSMAGIC studyMulti-Center Randomized Controlled TrialSickle cell vasoocclusive crisisAcute intervention trialDecreased opioid useFirst drug infusion
2013
An Analysis Of The Pediatric Sub-Group From The Phase 2 Study Of GMI 1070 – A Novel Agent For The Vaso-Occlusive Crisis Of Sickle Cell Anemia
McCavit T, Krishnamurti L, Hsu L, Quinn C, Odame I, Alvarez O, Driscoll C, Smith-Whitley K, Rhee S, Wun T, Telen M, Thackray H. An Analysis Of The Pediatric Sub-Group From The Phase 2 Study Of GMI 1070 – A Novel Agent For The Vaso-Occlusive Crisis Of Sickle Cell Anemia. Blood 2013, 122: 2206. DOI: 10.1182/blood.v122.21.2206.2206.Peer-Reviewed Original ResearchVaso-occlusive crisisSerious adverse eventsSickle cell anemiaAcute chest syndromeStudy drugPediatric subjectsAdult subjectsMaintenance dosesOpioid useSecondary outcomesMedian timePlacebo-controlled phase 2 trialCell anemiaRed blood cell transfusionPhase 3 clinical trialsStrong efficacy signalBlood cell transfusionPhase 2 studyPhase 2 trialKaplan-Meier methodVisual analog scaleInitial medical evaluationPan-selectin inhibitorAdvisory CommitteeMinimal safety concerns