PMID- 32282882
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210925
IS  - 2473-9537 (Electronic)
IS  - 2473-9529 (Print)
IS  - 2473-9529 (Linking)
VI  - 4
IP  - 7
DP  - 2020 Apr 14
TI  - IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, 
      blinded trial in childhood ITP.
PG  - 1492-1500
LID - 10.1182/bloodadvances.2019001343 [doi]
AB  - Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening 
      bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV 
      methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly 
      increase platelet counts (PCs). However, there are no controlled data to support 
      using combination therapy over IVIG alone. We conducted a randomized, 
      double-blind, placebo-controlled study to evaluate the rapidity of the PC 
      increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) 
      and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG 
      (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP 
      and PCs <20 x 109/L in whom physicians had decided to treat with IVIG. Thirty-two 
      children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC 
      of 9.2 x 109/L participated. Eighteen were randomized to regimen A and 14 to 
      regimen B. By 8 hours after initiating therapy, 55% of all children had a 
      PC >/=20 x 109/L (no group difference). By 24 hours, mean PCs were 76.9 x 109/L (B) 
      vs 55 x 109/L (A) (P = .06; P = .035 when adjusted for intergroup differences in 
      patient ages). No patient experienced severe bleeding/unexpected severe AEs. 
      There were statistically fewer IVIG-related headaches in the group receiving 
      combination therapy (P = .046). Our findings show a rapid response to IVIG 
      with/without steroids and provide evidence to support the use of IVMP+IVIG in 
      life-threatening situations. This trial was registered at www.clinicaltrials.gov 
      as #NCT00376077.
CI  - (c) 2020 by The American Society of Hematology.
FAU - Carcao, Manuel
AU  - Carcao M
AD  - Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick 
      Children and University of Toronto, Toronto, ON, Canada.
AD  - Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, 
      Toronto, ON, Canada.
FAU - Silva, Mariana
AU  - Silva M
AD  - Kingston General Hospital, Kingston, ON, Canada.
FAU - David, Michele
AU  - David M
AD  - Pediatric Hematology Oncology, CHU Ste-Justine, University of Montreal, Montreal, 
      QC, Canada.
FAU - Klaassen, Robert J
AU  - Klaassen RJ
AD  - Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, 
      Canada.
FAU - Steele, MacGregor
AU  - Steele M
AD  - Alberta Children's Hospital, Calgary, AB, Canada.
FAU - Price, Victoria
AU  - Price V
AD  - Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health 
      Centre, Halifax, NS, Canada; and.
FAU - Wakefield, Cindy
AU  - Wakefield C
AD  - Department of Nursing, Hospital for Sick Children, Toronto, ON, Canada.
FAU - Kim, Lussia
AU  - Kim L
AD  - Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, 
      Toronto, ON, Canada.
FAU - Stephens, Derek
AU  - Stephens D
AD  - Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, 
      Toronto, ON, Canada.
FAU - Blanchette, Victor S
AU  - Blanchette VS
AD  - Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick 
      Children and University of Toronto, Toronto, ON, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT00376077
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood Adv
JT  - Blood advances
JID - 101698425
RN  - 0 (Immunoglobulins, Intravenous)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Hemorrhage
MH  - Humans
MH  - *Immunoglobulins, Intravenous/adverse effects
MH  - Infant
MH  - Methylprednisolone/adverse effects
MH  - Platelet Count
MH  - *Purpura, Thrombocytopenic, Idiopathic/drug therapy
PMC - PMC7160294
COIS- Conflict-of-interest disclosure: The authors declare no competing financial 
      interests.
EDAT- 2020/04/14 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/04/13
CRDT- 2020/04/14 06:00
PHST- 2019/12/12 00:00 [received]
PHST- 2020/03/09 00:00 [accepted]
PHST- 2020/04/14 06:00 [entrez]
PHST- 2020/04/14 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/04/13 00:00 [pmc-release]
AID - S2473-9529(20)31410-5 [pii]
AID - 2019/ADV2019001343 [pii]
AID - 10.1182/bloodadvances.2019001343 [doi]
PST - ppublish
SO  - Blood Adv. 2020 Apr 14;4(7):1492-1500. doi: 10.1182/bloodadvances.2019001343.