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 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.

Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer's disease: a randomized double-blind pilot study

2011 ◽  
Vol 23 (9) ◽  
pp. 1515-1519 ◽  
Author(s):  
Yoram Barak ◽  
Igor Plopski ◽  
Shelly Tadger ◽  
Diana Paleacu
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Controlled Trial ◽  
Treated Group ◽  
Psychotic Symptoms ◽  
Completion Rates ◽  
Double Blind ◽  
Once Daily ◽  
Risperidone Group

ABSTRACTBackground: Antipsychotics are frequently used to treat psychosis, aggression and agitation in patients with Alzheimer's disease (AD), but safety warnings abound. Escitalopram was investigated since citalopram has demonstrated some effectiveness in AD. We compared escitalopram and risperidone for psychotic symptoms and agitation associated with AD.Methods: Inpatients with AD, who had been hospitalized because of behavioral symptoms, were recruited to a six-week randomized, double-blind, controlled trial. Participants (n = 40) were randomized to once daily risperidone 1 mg or escitalopram 10 mg.Results: The NPI total score improved in both groups. Onset was earlier in the risperidone-treated group, but improvement did not significantly differ between groups by study end. Completion rates differed for escitalopram (75%) and risperidone (55%), mainly due to adverse events. There were no adverse events in the escitalopram group, while in the risperidone group two patients suffered severe extrapyramidal symptoms and four patients suffered acute physical illness necessitating transfer to general hospital.Conclusion: Escitalopram and risperidone did not differ in efficacy in reducing psychotic symptoms and agitation in patients with AD. Completion rates were higher for escitalopram-treated patients. Replication in larger trials with ambulatory patients is needed.

A placebo-controlled trial of aprepitant for cough in lung cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
Amelie Sylvia Mary Harle ◽  
Jaclyn A Smith ◽  
Alex Molassiotis ◽  
Kimberley Lofthouse ◽  
Rachel Dockry ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Controlled Trial ◽  
Performance Status ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Scale Scores ◽  
Never Smokers ◽  
Neurokinin 1 ◽  
Score Range ◽  
Clinical Trial Information

2 Background: There are no evidence-based therapies for cough in lung cancer (LC).The neurokinin-1 (NK-1) pathway is implicated in cough. Aprepitant is an NK-1 antagonist used as an antiemetic. We assess aprepitant as an antitussive, using objective daytime ambulatory cough monitoring (ACM) as the primary endpoint. Methods: LC patients with a “bothersome” cough were enrolled on an exploratory single-arm randomised double-blind crossover trial and received 125mg aprepitant on day 1 and 80mg on days 2 and 3 or matched placebo capsules. After a 3 day wash out,patients crossed over to placebo or aprepitant for 3 days (days 7-9). They completed ACM and validated subjective cough tools. Results: 20 LC patients were enrolled between 7th Oct 2013-3rd Nov 2014; mean age 66 yrs (SD 7.69); 60% (n=12) female; 70% (n=14) ex, 25% (n=5) current and 5% (n=1) never smokers respectively. 20% (n=4), 55% (n=11) and 25% (n=5) had a performance status of 0, 1 and 2 respectively. The majority (80% n=16) had non-small cell LC; half (n=10) had advanced stage; 20% (n=4) were on anticancer therapy. Daytime cough frequency was 15.9 (95%CI 10.1-28.3 n=19), 12.8 (95% CI 8.7-18.8 n=18) and 16.2 (11.3-23.0 n=19) coughs/hr at baseline, on aprepitant and on placebo respectively: p=0.03. Visual analogue scale scores (range 0-100, high score=worse severity) were 57.0mm (95% CI 47.4-67.2 n=19), 40.8mm, (95%CI 34.3-47.3 n=18), and 49.8mm (95%CI 44.2-55.4 n=19) at baseline, on aprepitant and on placebo respectively: p=0.008. The Manchester Cough in Lung Cancer Scale score (range 1-50, high score = worse cough impact) was 25.2 (95%CI 23.0-28.0 n=19), 19.5 (95%CI 17.8-21.2 n=18) and 21.7 (20.3-23.1 n=18) at baseline, on aprepitant and on placebo respectively: p<0.001.There were no serious adverse events. Conclusions: This is the first trial to assess the efficacy of a novel antitussive using validated subjective and objective cough tools in LC and the first to investigate a centrally acting NK-1 antagonist in humans. Aprepitant treatment was associated with statistically significant improvements in objective and subjective scores. The NK-1 receptors may be key mediators in cough in LC. It is possible to run a robust trial using validated measures with clinically meaningful endpoints in a LC population. Clinical trial information: ISRCTN16200035.

scholarly journals The Evaluation of the Body Weight Lowering Effects of Herbal Extract THI on Exercising Healthy Overweight Humans: A Randomized Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Soo Hyun Cho ◽  
Yoosik Yoon ◽  
Young Yang
Keyword(s):  
Body Weight ◽  
Controlled Trial ◽  
Safety Evaluation ◽  
Hdl Cholesterol ◽  
Treated Group ◽  
The Body ◽  
Herbal Extract ◽  
Double Blind ◽  
The Difference ◽  
Group 2

We investigated the effects of herbal extracts, a mixture of Scutellariae Radix and Platycodi Radix containing the active ingredients Baicalin and Saponin (target herbal ingredient (THI)), on lowering body weight. The present study was a prospective, randomized, double-blind, and placebo-controlled trial carried out at the outpatient department of a hospital over a period of 2 months. Group 1 patients (n=30) received THI, and group 2 patients (n=23) received placebo three times a day before meals. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and glucose were measured at baseline and again at the 2nd month. For safety evaluation, various hematological and biochemical parameters were assessed. Values of mean change of weight in the THI-treated group were−1.16±1.41 kg and in the placebo-treated group were−0.24±1.70 kg, respectively. The difference in mean change of weight in the THI-treated group compared with that in the placebo-treated group was statistically significant (P<0.05). The incidence of subjective and objective adverse drug reactions was insignificant (P>0.05). THI was statistically significant in its effectiveness on the weight loss.

Sodium fluoride in otosclerosis treatment: review

2010 ◽  
Vol 124 (6) ◽  
pp. 583-586 ◽  
Author(s):  
A S Cruise ◽  
A Singh ◽  
R E Quiney
Keyword(s):  
Sodium Fluoride ◽  
Group Treatment ◽  
Controlled Trial ◽  
Treated Group ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Control Series ◽  
Treatment Review ◽  
Pubmed Database ◽  
Vestibular Symptoms

AbstractObjectives:To review the current literature on the use of sodium fluoride in the treatment of otosclerosis.Design:A literature review was conducted, searching the Medline and PubMed database from 1966 to 2009, using the terms ‘otosclerosis’ and ‘fluoride’. Article abstracts were reviewed and relevant full articles acquired.Results:There has been only one double-blind, placebo-controlled trial of the use of sodium fluoride in otosclerosis patients, and this found a reduced incidence of deterioration in hearing after two years in the treatment group. Several case–control series have described a hearing benefit in the sodium fluoride treated group. Treatment doses vary greatly, and there is no evidence regarding the optimum duration of treatment.Conclusions:There is low quality evidence suggesting that sodium fluoride may be of benefit to preserve hearing and reduce vestibular symptoms in patients with otosclerosis.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

scholarly journals Metal excretion and magnesium retention in patients with intermittent claudication treated with intravenous disodium EDTA

1996 ◽  
Vol 42 (12) ◽  
pp. 1938-1942 ◽  
Author(s):  
B Guldager ◽  
P J Jørgensen ◽  
P Grandjean
Keyword(s):  
Intermittent Claudication ◽  
Controlled Trial ◽  
Serum Zinc ◽  
Blood Lead ◽  
Treated Group ◽  
The Body ◽  
Control Group ◽  
Disodium Edta ◽  
Double Blind ◽  
Blood Concentrations

Abstract Sixty patients with intermittent claudication participated in a double-blind placebo-controlled trial of 20 courses of intravenous chelation therapy with 3 g of disodium EDTA vs placebo during 5-9 weeks. After the first infusion, the 24-h urinary excretion of lead and zinc was approximately 25-fold higher in the EDTA-treated group; relative differences for copper and calcium were smaller. Urinary magnesium excretion in the EDTA-treated group was one-third less than in the control group. After the treatment period, the blood lead concentration had decreased by approximately 73% and the serum zinc concentration by approximately 34%; other changes in blood concentrations were negligible. The loss of essential minerals and the possible redistribution of lead in the body may constitute a disadvantage that should be taken into account in repeated intravenous EDTA treatment.

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