Severe bleeding events in adults and children with primary immune thrombocytopenia

A systematic review

Cindy E Neunert, N. Noroozi, G. Norman, G. R. Buchanan, J. Goy, I. Nazi, J. G. Kelton, D. M. Arnold

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

Summary: Background: The burden of severe bleeding in adults and children with immune thrombocytopenia (ITP) has not been established. Objectives: To describe the frequency and severity of bleeding events in patients with ITP, and the methods used to measure bleeding in ITP studies. Patients/Methods: We performed a systematic review of all prospective ITP studies that enrolled 20 or more patients. Two reviewers searched Medline, Embase, CINAHL and the Cochrane registry up to May 2014. Overall weighted proportions were estimated using a random effects model. Measurement properties of bleeding assessment tools were evaluated. Results: We identified 118 studies that reported bleeding (n = 10 908 patients). Weighted proportions for intracerebral hemorrhage (ICH) were 1.4% for adults (95% confidence interval [CI], 0.9-2.1%) and 0.4% for children (95% CI, 0.2-0.7%; P < 0.01), most of whom had chronic ITP. The weighted proportion for severe (non-ICH) bleeding was 9.6% for adults (95% CI, 4.1-17.1%) and 20.2% for children (95% CI, 10.0-32.9%; P < 0.01) with newly-diagnosed or chronic ITP. Methods of reporting and definitions of severe bleeding were highly variable in primary studies. Two bleeding assessment tools (Buchanan 2002 for children; Page 2007 for adults) demonstrated adequate inter-rater reliability and validity in independent assessments. Conclusions: ICH was more common in adults and tended to occur during chronic ITP; other severe bleeds were more common in children and occurred at all stages of disease. Reporting of non-ICH bleeding was variable across studies. Further attention to ITP-specific bleeding measurement in clinical trials is needed to improve standardization of this important outcome for patients.

Original languageEnglish (US)
Pages (from-to)457-464
Number of pages8
JournalJournal of Thrombosis and Haemostasis
Volume13
Issue number3
DOIs
StatePublished - Mar 1 2015

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Idiopathic Thrombocytopenic Purpura
Hemorrhage
Confidence Intervals
Cerebral Hemorrhage
Reproducibility of Results
Registries
Clinical Trials

Keywords

  • Bleeding
  • Intracranial hemorrhages
  • Outcome assessment health care
  • Platelets
  • Purpura, thrombocytopenic

ASJC Scopus subject areas

  • Hematology

Cite this

Neunert, C. E., Noroozi, N., Norman, G., Buchanan, G. R., Goy, J., Nazi, I., ... Arnold, D. M. (2015). Severe bleeding events in adults and children with primary immune thrombocytopenia: A systematic review. Journal of Thrombosis and Haemostasis, 13(3), 457-464. https://doi.org/10.1111/jth.12813

Severe bleeding events in adults and children with primary immune thrombocytopenia : A systematic review. / Neunert, Cindy E; Noroozi, N.; Norman, G.; Buchanan, G. R.; Goy, J.; Nazi, I.; Kelton, J. G.; Arnold, D. M.

In: Journal of Thrombosis and Haemostasis, Vol. 13, No. 3, 01.03.2015, p. 457-464.

Research output: Contribution to journalArticle

Neunert, CE, Noroozi, N, Norman, G, Buchanan, GR, Goy, J, Nazi, I, Kelton, JG & Arnold, DM 2015, 'Severe bleeding events in adults and children with primary immune thrombocytopenia: A systematic review', Journal of Thrombosis and Haemostasis, vol. 13, no. 3, pp. 457-464. https://doi.org/10.1111/jth.12813
Neunert, Cindy E ; Noroozi, N. ; Norman, G. ; Buchanan, G. R. ; Goy, J. ; Nazi, I. ; Kelton, J. G. ; Arnold, D. M. / Severe bleeding events in adults and children with primary immune thrombocytopenia : A systematic review. In: Journal of Thrombosis and Haemostasis. 2015 ; Vol. 13, No. 3. pp. 457-464.
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T2 - A systematic review

AU - Neunert, Cindy E

AU - Noroozi, N.

AU - Norman, G.

AU - Buchanan, G. R.

AU - Goy, J.

AU - Nazi, I.

AU - Kelton, J. G.

AU - Arnold, D. M.

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N2 - Summary: Background: The burden of severe bleeding in adults and children with immune thrombocytopenia (ITP) has not been established. Objectives: To describe the frequency and severity of bleeding events in patients with ITP, and the methods used to measure bleeding in ITP studies. Patients/Methods: We performed a systematic review of all prospective ITP studies that enrolled 20 or more patients. Two reviewers searched Medline, Embase, CINAHL and the Cochrane registry up to May 2014. Overall weighted proportions were estimated using a random effects model. Measurement properties of bleeding assessment tools were evaluated. Results: We identified 118 studies that reported bleeding (n = 10 908 patients). Weighted proportions for intracerebral hemorrhage (ICH) were 1.4% for adults (95% confidence interval [CI], 0.9-2.1%) and 0.4% for children (95% CI, 0.2-0.7%; P < 0.01), most of whom had chronic ITP. The weighted proportion for severe (non-ICH) bleeding was 9.6% for adults (95% CI, 4.1-17.1%) and 20.2% for children (95% CI, 10.0-32.9%; P < 0.01) with newly-diagnosed or chronic ITP. Methods of reporting and definitions of severe bleeding were highly variable in primary studies. Two bleeding assessment tools (Buchanan 2002 for children; Page 2007 for adults) demonstrated adequate inter-rater reliability and validity in independent assessments. Conclusions: ICH was more common in adults and tended to occur during chronic ITP; other severe bleeds were more common in children and occurred at all stages of disease. Reporting of non-ICH bleeding was variable across studies. Further attention to ITP-specific bleeding measurement in clinical trials is needed to improve standardization of this important outcome for patients.

AB - Summary: Background: The burden of severe bleeding in adults and children with immune thrombocytopenia (ITP) has not been established. Objectives: To describe the frequency and severity of bleeding events in patients with ITP, and the methods used to measure bleeding in ITP studies. Patients/Methods: We performed a systematic review of all prospective ITP studies that enrolled 20 or more patients. Two reviewers searched Medline, Embase, CINAHL and the Cochrane registry up to May 2014. Overall weighted proportions were estimated using a random effects model. Measurement properties of bleeding assessment tools were evaluated. Results: We identified 118 studies that reported bleeding (n = 10 908 patients). Weighted proportions for intracerebral hemorrhage (ICH) were 1.4% for adults (95% confidence interval [CI], 0.9-2.1%) and 0.4% for children (95% CI, 0.2-0.7%; P < 0.01), most of whom had chronic ITP. The weighted proportion for severe (non-ICH) bleeding was 9.6% for adults (95% CI, 4.1-17.1%) and 20.2% for children (95% CI, 10.0-32.9%; P < 0.01) with newly-diagnosed or chronic ITP. Methods of reporting and definitions of severe bleeding were highly variable in primary studies. Two bleeding assessment tools (Buchanan 2002 for children; Page 2007 for adults) demonstrated adequate inter-rater reliability and validity in independent assessments. Conclusions: ICH was more common in adults and tended to occur during chronic ITP; other severe bleeds were more common in children and occurred at all stages of disease. Reporting of non-ICH bleeding was variable across studies. Further attention to ITP-specific bleeding measurement in clinical trials is needed to improve standardization of this important outcome for patients.

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KW - Platelets

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