Bleeding and infection with external ventricular drainage: A systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial

Mahua Dey, Agnieszka Stadnik, Fady Riad, Lingjiao Zhang, Nichol McBee, Carlos Kase, Juan Carhuapoma, Malathi Ram, Karen Lane, Noeleen Ostapkovich, Francois Aldrich, Charlene Aldrich, Jack Jallo, Ken Butcher, Ryan Snider, Daniel F Hanley, Wendy C Ziai, Issam A. Awad

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. OBJECTIVE: To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. METHODS: Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. RESULTS: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. CONCLUSION: Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

Original languageEnglish (US)
Pages (from-to)291-300
Number of pages10
JournalNeurosurgery
Volume76
Issue number3
DOIs
StatePublished - Jan 1 2015

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Drainage
Hemorrhage
Infection
Bacterial Meningitides
Tissue Plasminogen Activator
Random Allocation
Meta-Analysis
Software
Catheters
Tomography
Placebos
Prospective Studies
Injections

Keywords

  • EVD
  • EVD complications
  • External ventricular drain
  • Hemorrhage
  • Infection
  • Intraventricular Hemorrhage

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

Bleeding and infection with external ventricular drainage : A systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial. / Dey, Mahua; Stadnik, Agnieszka; Riad, Fady; Zhang, Lingjiao; McBee, Nichol; Kase, Carlos; Carhuapoma, Juan; Ram, Malathi; Lane, Karen; Ostapkovich, Noeleen; Aldrich, Francois; Aldrich, Charlene; Jallo, Jack; Butcher, Ken; Snider, Ryan; Hanley, Daniel F; Ziai, Wendy C; Awad, Issam A.

In: Neurosurgery, Vol. 76, No. 3, 01.01.2015, p. 291-300.

Research output: Contribution to journalArticle

Dey, Mahua ; Stadnik, Agnieszka ; Riad, Fady ; Zhang, Lingjiao ; McBee, Nichol ; Kase, Carlos ; Carhuapoma, Juan ; Ram, Malathi ; Lane, Karen ; Ostapkovich, Noeleen ; Aldrich, Francois ; Aldrich, Charlene ; Jallo, Jack ; Butcher, Ken ; Snider, Ryan ; Hanley, Daniel F ; Ziai, Wendy C ; Awad, Issam A. / Bleeding and infection with external ventricular drainage : A systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial. In: Neurosurgery. 2015 ; Vol. 76, No. 3. pp. 291-300.
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abstract = "BACKGROUND: Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. OBJECTIVE: To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. METHODS: Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. RESULTS: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3{\%}) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8{\%}) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4{\%}) suffered symptomatic hemorrhages. Eleven cases (4.4{\%}) had culture-proven bacterial meningitis or ventriculitis. CONCLUSION: Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.",
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T1 - Bleeding and infection with external ventricular drainage

T2 - A systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial

AU - Dey, Mahua

AU - Stadnik, Agnieszka

AU - Riad, Fady

AU - Zhang, Lingjiao

AU - McBee, Nichol

AU - Kase, Carlos

AU - Carhuapoma, Juan

AU - Ram, Malathi

AU - Lane, Karen

AU - Ostapkovich, Noeleen

AU - Aldrich, Francois

AU - Aldrich, Charlene

AU - Jallo, Jack

AU - Butcher, Ken

AU - Snider, Ryan

AU - Hanley, Daniel F

AU - Ziai, Wendy C

AU - Awad, Issam A.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - BACKGROUND: Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. OBJECTIVE: To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. METHODS: Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. RESULTS: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. CONCLUSION: Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

AB - BACKGROUND: Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. OBJECTIVE: To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. METHODS: Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. RESULTS: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. CONCLUSION: Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

KW - EVD

KW - EVD complications

KW - External ventricular drain

KW - Hemorrhage

KW - Infection

KW - Intraventricular Hemorrhage

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