scholarly journals Permanent CSF shunting after intraventricular hemorrhage in the CLEAR III trial

Neurology ◽  
2017 ◽  
Vol 89 (4) ◽  
pp. 355-362 ◽  
Author(s):  
Santosh B. Murthy ◽  
Issam Awad ◽  
Sagi Harnof ◽  
Francois Aldrich ◽  
Mark Harrigan ◽  
...  
Keyword(s):  
Intracranial Pressure ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Clot Lysis ◽  
Double Blind ◽  
Csf Shunts ◽  
Radiographic Findings ◽  
Csf Shunting ◽  
Csf Diversion

Objective:To study factors associated with permanent CSF diversion and the relationship between shunting and functional outcomes in spontaneous intraventricular hemorrhage (IVH).Methods:Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III), a randomized, multicenter, double-blind, placebo-controlled trial, was conducted to determine if pragmatically employed external ventricular drainage (EVD) plus intraventricular alteplase improved outcome, in comparison to EVD plus saline. Outcome measures were predictors of shunting and blinded assessment of mortality and modified Rankin Scale at 180 days.Results:Among the 500 patients with IVH, CSF shunting was performed in 90 (18%) patients at a median of 18 (interquartile range [IQR] 13–30) days. Patient demographics and IVH characteristics were similar among patients with and without shunts. In the multivariate analysis, black race (odds ratio [OR] 1.98; 95% confidence interval [CI] 1.18–3.34), duration of EVD (OR 1.10; CI 1.05–1.15), placement of more than one EVD (OR 1.93; CI 1.13–3.31), daily drainage CSF per 10 mL (OR 1.07; CI 1.04–1.10), and intracranial pressure >30 mm Hg (OR 1.70; CI 1.09–2.88) were associated with higher odds of permanent CSF shunting. Patients who had CSF shunts had similar odds of 180-day mortality, while survivors with shunts had increased odds of poor functional outcome, compared to survivors without shunts.Conclusions:Among patients with spontaneous IVH requiring emergency CSF diversion, those with early elevated intracranial pressure, high CSF output, and placement of more than one EVD are at increased odds of permanent ventricular shunting. Administration of intraventricular alteplase, early radiographic findings, and CSF measures were not useful predictors of permanent CSF diversion.

Abstract 215: Evaluation of Intracranial Pressure and Cerebral Perfusion Pressure in the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Trial (CLEAR III)

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Wendy Ziai ◽  
Steven Mayo ◽  
William D Freeman ◽  
Nichol McBee ◽  
Rachel Dlugash ◽  
...  
Keyword(s):  
Intracranial Pressure ◽  
Cerebral Perfusion Pressure ◽  
Intraventricular Hemorrhage ◽  
Cerebral Perfusion ◽  
Perfusion Pressure ◽  
Randomized Study ◽  
Recombinant Tissue Plasminogen Activator ◽  
Ventricular System ◽  
Clot Lysis ◽  
Double Blind

Background: Elevated intracranial pressure (ICP) and inadequate cerebral perfusion pressure (CPP) are mechanisms causing poor outcomes in spontaneous intraventricular hemorrhage (IVH). We characterized intracranial hypertension in severe IVH requiring extraventricular drainage (EVD). Methods: Prospective analysis of ICP in all 500 patients enrolled in the CLEAR III trial, a multicenter, double-blind, randomized study comparing EVD + intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD + placebo for treatment of obstructive IVH and intracerebral hemorrhage (ICH) volume <30cc. Maximum and minimum ICP/CPP were recorded every 4 hours until 7 days post randomization (rand), analyzed at pre-defined thresholds and compared by clinical and radiological variables. Results: of 23,406 ICP readings, maximum ICP ranged from 0-97 mmHg (median, IQR; 11,8); 90.7% (21,223) were ≤20mmHg, 1.8% >30, 0.5% >40, and 0.2% > 50mm Hg. Proportion of threshold events >20mmHg were more frequent with persistent closure of the lower ventricular system after day 3 (p=0.02), and was correlated with initial and end of treatment (72 hours post rand) ICH volumes (p=0.01, p=0.04, respectively). ICP elevation >20mmHg occurred during a required 1 hr EVD closure interval after 566/3712 (15.3%) study agent injections. Early re-opening of the EVD occurred in 3.9%. Shunting for hydrocephalus occurred in 18.6% over 1 year follow-up and was associated with % of high ICP events >20 and 30 mmHg (p=0.01 for both). After adjustment for ICH severity factors and IVH volume, % of ICP readings>20 mmHg was significantly associated with 30 and 180 day mortality (p=0.01; p=0.03 respectively), and borderline with modified Rankin Scale (mRS4-6) (p=0.09; p=0.11 respectively). Proportion of CPP readings <70mmHg was associated with day 30 poor mRS (p=0.02), with a weaker association for day 180 mRS (p=0.07). Conclusions: Elevated ICP and inadequate CPP are not infrequent during monitoring and EVD drainage in severe IVH and predict higher short and long-term mortality. Early opening of the lower ventricular system may reduce high ICP events. These results permit future correlation of ICP and CPP with treatment rendered (thrombolysis vs placebo), with upcoming unblinding of the trial.

scholarly journals Rapid Pore Cranial Drilling With External Ventricular Drainage for Treatment of Intraventricular Hemorrhage: A 36-Year Case Series

2015 ◽  
Vol 100 (6) ◽  
pp. 1117-1123 ◽  
Author(s):  
Wei Zhang ◽  
Lin Wei ◽  
Gang Li ◽  
Jinlong Sun ◽  
Peng Jin ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Intraventricular Hemorrhage ◽  
Blood Clot ◽  
Controlled Trial ◽  
Case Series ◽  
External Ventricular Drainage ◽  
Therapeutic Effects ◽  
Ventricular Drainage ◽  
Drilling Technique ◽  
Conventional Drilling

This study aimed to describe the technique details of rapid pore cranial drilling with external ventricular drainage and document its clinical outcomes by highlighting the advantages over the traditional and modified cranial drilling technique. Intraventricular hemorrhage is one of the most severe subtypes of hemorrhagic stroke with high mortality. The amount of blood in the ventricles is associated with severity of outcomes, and fast removal of the blood clot is the key to a good prognosis. Between 1977 and 2013, 3773 patients admitted for intraventricular hemorrhage underwent rapid pore cranial drilling drainage. The therapeutic effects and clinical outcomes were retrospectively analyzed. Of these patients, 1049 (27.8%) experienced complete remission, 1788 (47.4%) had improved condition, and 936 (24.8%) died. A total of 3229 (85.6%) patients gained immediate remission. One typical case was illustrated to demonstrate the efficacy of the rapid pore drilling technique. Rapid pore cranial drilling drainage in patients with intraventricular hemorrhage is fast, effective, and provides immediate relief in patients with severe conditions. It could be a better alternative to the conventional drilling approach for treatment of intraventricular hemorrhage. A randomized controlled trial for direct comparison between the rapid pore cranial drilling drainage and conventional drilling technique is in urgent need.

scholarly journals A Randomized, Double‐Blind, Placebo‐Controlled Trial of Acetazolamide for the Treatment of Elevated Intracranial Pressure in Cryptococcal Meningitis

2002 ◽  
Vol 35 (6) ◽  
pp. 769-772 ◽  
Author(s):  
Paul N. Newton ◽  
Le Hung Thai ◽  
Nguyen Quoc Tip ◽  
Jennifer M. Short ◽  
Wirongrong Chierakul ◽  
...  
Keyword(s):  
Intracranial Pressure ◽  
Cryptococcal Meningitis ◽  
Controlled Trial ◽  
Elevated Intracranial Pressure ◽  
Double Blind ◽  
Double Blind Placebo

Abstract WMP86: Evaluation of Cerebrospinal Fluid Dynamics and External Ventricular Drain Management in the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage trial (CLEAR III)

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Wendy Ziai ◽  
Mariam Bhuiyan ◽  
Nichol McBee ◽  
Rachel Dlugash ◽  
Kevin Sheth ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Intraventricular Hemorrhage ◽  
Obstructive Hydrocephalus ◽  
External Ventricular Drain ◽  
Randomized Study ◽  
Recombinant Tissue Plasminogen Activator ◽  
Clot Lysis ◽  
Csf Dynamics ◽  
Double Blind ◽  
Csf Drainage

Background: Acute obstructive hydrocephalus secondary to spontaneous intracerebral/intraventricular hemorrhage (ICH/IVH) requires early cerebrospinal fluid (CSF) drainage to reduce intracranial pressure (ICP). Extensive CSF drainage may reduce IVH clot burden. We characterize CSF dynamics, strategies and impact on end of treatment (EOT) IVH volume (72 hours post randomization [Rand]) in the CLEAR III trial. Methods: Prospective analysis of CSF output in all 500 patients enrolled in the CLEAR III trial, a multicenter, double-blind, randomized study comparing EVD + intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD + placebo for treatment of obstructive IVH and intracerebral hemorrhage (ICH) volume <30cc. CSF output was recorded every 4 hours until 7 days post Rand, and compared by clinical and radiological variables. Results: Daily median CSF output in the first week was 188cc (IQR: 125, 252). Maximum daily EVD drip settings were <10mmHg in 27.8%, =10 in 44.1% and >10 in 28.1%. Independent predictors of higher daily CSF output after adjustment for initial IVH volume (p=0.04) were lower drip setting (p<0.001), lower age (p<0.001), male sex (p=0.03), dual EVD (p=0.005), CSF protein (p<0.001) and ICP>20mmHg (P=0.007). Both EOT IVH volume and change in IVH volume (ChgIVH) (over 1 st week) were independently associated with total CSF output (P=0.004/<0.001, respectively), and initial IVH volume (P<0.001/<0.001)). Early opening of 3 rd and 4 th ventricle (P=0.03) was associated with lower EOT volumes, while CSF protein (P=0.02), and side of EVD ipsilateral to largest IVH (P=0.04) were associated with ChgIVH. Shunting for hydrocephalus was performed in 18.6% over 1 year follow-up and was associated with higher total CSF output over first week (P<0.001). Conclusions: CSF circulation in severe IVH can be assessed by CSF output which is associated with EVD drip management and other clinical variables. EOT IVH volume and IVH volume reduction are important surrogate endpoints which are related to CSF dynamics. VP shunt requirement in spontaneous IVH is associated with early CSF output levels. These results permit future correlation of CSF output with treatment rendered (thrombolysis versus placebo) with upcoming unblinding of the trial.

Intraventricular Thrombolysis Speeds Blood Clot Resolution: Results of a Pilot, Prospective, Randomized, Double-blind, Controlled Trial

Neurosurgery ◽  
2004 ◽  
Vol 54 (3) ◽  
pp. 577-584 ◽  
Author(s):  
Neal J. Naff ◽  
Daniel F. Hanley ◽  
Penelope M. Keyl ◽  
Stanley Tuhrim ◽  
Michael Kraut ◽  
...  
Keyword(s):  
Intraventricular Hemorrhage ◽  
Blood Clot ◽  
Controlled Trial ◽  
Treated Group ◽  
Ventricular Drainage ◽  
Double Blind ◽  
Clinical Criteria ◽  
Computed Tomographic ◽  
Blood Clots ◽  
Scale Scores

Abstract OBJECTIVE Animal models and clinical studies suggest that intraventricular thrombolysis improves clot resolution and clinical outcomes among patients with intraventricular hemorrhage. However, this intervention may increase the rates of rebleeding and infection. To assess the safety and efficacy of intraventricular thrombolysis, we conducted a pilot, randomized, double-blind, controlled, multicenter study. METHODS Patients with intraventricular hemorrhage requiring ventriculostomy were randomized to receive intraventricular injections of normal saline solution or urokinase (25,000 international units) at 12-hour intervals. Injections continued until ventricular drainage was discontinued according to prespecified clinical criteria. Head computed tomographic scans were obtained daily, for quantitative determinations of intraventricular hemorrhage volumes. The rate of clot resolution was estimated for each group. RESULTS Twelve subjects were enrolled (urokinase, seven patients; placebo, five patients). Commercial withdrawal of urokinase precluded additional enrollment. The urokinase and placebo groups were similar with respect to age (49.6 versus 55.2 yr, P = 0.43) and presenting Glasgow Coma Scale scores (7.14 versus 8.00, P = 0.72). Randomization to the urokinase treatment arm (P = 0.02) and female sex (P = 0.008) favorably affected the clot resolution rate. The sex-adjusted clot half-life for the urokinase-treated group was reduced 44.6%, compared with the value for the placebo group (4.69 versus 8.48 d). CONCLUSION Intraventricular thrombolysis with urokinase speeds the resolution of intraventricular blood clots, compared with treatment with ventricular drainage alone.

scholarly journals Intraoperative Measurement of Intracranial Pressure During Cranial Vault Remodeling in Children with Craniosynostosis

2022 ◽  
Author(s):  
Sonia Bansal ◽  
Subhas Konar ◽  
Dhaval Shukla ◽  
Dwarakanath Srinivas ◽  
Vishram Pandey ◽  
...  
Keyword(s):  
Intracranial Pressure ◽  
Intraoperative Monitoring ◽  
External Ventricular Drainage ◽  
Cranial Vault ◽  
Icp Monitoring ◽  
Height Reduction ◽  
Csf Diversion ◽  
The Mean ◽  
Entire Procedure ◽  
Cranial Vault Remodeling

Abstract Purpose In this study, we analyzed the utility of intracranial pressure (ICP) monitoring intraoperatively for deciding height reduction and need for cerebrospinal fluid (CSF) diversion during cranial vault remodeling in children with multisutural craniosynostosis (CS). Methods This is a retrospective observational study of children who underwent surgery for CS and ICP monitoring during surgery. The ICP was monitored using an external ventricular drainage catheter. The ICP monitoring was continued during the entire procedure. Results A total of 28 (19 boys) children with the involvement of two or more sutures underwent ICP monitoring during surgery. The commonest pattern of suture involvement was bicoronal seen in 16 (57.1%) children followed by pancraniosynostoses in eight (28.6%) cases. The mean opening ICP was 23 mm Hg, which dropped to 10.9 mm Hg after craniotomy. The ICP increased transiently to 19.5 mm Hg after height reduction, and the mean ICP at closure was 16.2 mm Hg. The ICP recordings helped in undoing the height reduction in two children and ventriculoperitoneal shunt after surgery in two children. Conclusions Intraoperative monitoring of ICP helps in deciding the type of cranial vault remodeling and the need for CSF diversion after surgery.

scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2020 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background: The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.Methods: The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months after surgery.Discussion: The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.Trial registration: ClinicalTrials.gov, NCT04037267. Registered on 26 July 2019.

scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2019 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.Methods The trial is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months postoperatively after the two approaches.Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

scholarly journals Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

2020 ◽  
Author(s):  
Junhao Zhu ◽  
Chao Tang ◽  
Zixiang Cong ◽  
Jin Yang ◽  
Xiangming Cai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
External Ventricular Drainage ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Ventricular Drainage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Tertiary Hospitals

Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone. Methods The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months postoperatively. Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

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