scholarly journals Low Dose Perioperative Intravenous Tranexamic Acid in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Placebo Controlled Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mahdi Motififard ◽  
Mohammad Ali Tahririan ◽  
Mehdi Saneie ◽  
Sajad Badiei ◽  
Amin Nemati
Keyword(s):  
Tranexamic Acid ◽  
Primary Outcome ◽  
Low Dose ◽  
Study Groups ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Duration Of Hospitalization ◽  
Slow Infusion ◽  
The Difference

Background and Objectives. The null hypothesis of this study was that TA has no effect on postsurgical bleeding in patients undergoing TKA. Methods. This study was a double-blind randomized trial. In the first group (T) patients received 500 mg of intravenous Tranexamic acid (TA) twice (once preoperatively and once 3 hours postoperatively) and in the second group (P) they received slow infusion of normal saline as placebo. The primary outcome of the study was the level of Hb 48 hours after surgery. Results. Hb levels 48 hours after surgery as the primary outcome were 10.92±0.97 and 10.23±0.98 (g/dL) in groups T and P, respectively, and the difference was statistically significant (P=0.001). Statistically significant differences were also observed in Hb levels 6 and 24 hours after surgery, the drain output 48 hours after surgery, and the number of units of packed cells transfused between study groups (P<0.05). There was no significant difference in duration of hospitalization between the study groups (P = n.s.). Conclusions. The low dose perioperative intravenous TA significantly reduces blood loss, requirement for blood transfusion, and drain output in patients undergoing TKA. However, duration of hospitalization did not change significantly.

scholarly journals Comparing Efficacy and Safety of Oral Tranexamic Acid and 4% Topical Hydroquinone Cream in Melasma Treatment: A Randomized Controlled Clinical Trial and Review of Literature

2019 ◽  
Vol 11 (4) ◽  
pp. 119-128
Author(s):  
Reza Yaghoobi ◽  
Samin Vala ◽  
Nader Pazyar ◽  
Maryam Zeinali ◽  
Saeed Hesam
Keyword(s):  
Clinical Trial ◽  
Tranexamic Acid ◽  
Skin Pigmentation ◽  
Severity Index ◽  
Study Groups ◽  
Controlled Clinical Trial ◽  
Therapeutic Effects ◽  
Common Skin ◽  
The Difference ◽  
Group B

AbstractIntroduction. Melasma is a common skin pigmentation disorder affecting a patient’s life psychologically and socially. Topical medications or lasers can have temporary and limited therapeutic effects on melasma. Material and Methods. This study is a prospective clinical trial comparing therapeutic effects of oral Tranexamic acid (TXA) and topical Hydroquinone (HQ) cream. A total number of 69 patients were examined. During the study, 10 patients failed to appear for the follow-up and 59 of them completed the trial. The patients were also divided randomly into two groups. Group A received TXA capsule 250 mg every 12 hours and group B received 4% topical HQ cream day and night. The patients from both groups were treated for 3 months. Melasma Area and Severity Index (MASI) scores were then calculated at the baseline, 4 weeks, and 12 weeks into the treatment and 3 months after the end of intervention. Results. MASI baseline, 4 weeks,12 weeks, and 24 weeks in TXA group were 21.66, 13.69, 9.10, 9.24; respectively. Reduction of MASI between baseline and 4 weeks was statistically significant. Such a decreasing trend in MASI scores between baseline and 12 weeks was also reported as statistically significant (p=0.001). In the HQ group, MASI baseline,4 weeks, 12 weeks, and 24 weeks were 21.46, 13.57, 10.93, 11.20; respectively. Reduction of MASI scores between baseline and 4 weeks was statistically significant. Moreover, a decline in MASI scores was observed between baseline and 12 weeks that was statistically significant (p=0.001). Considering both groups MASI scores were reduced but the difference between two study groups was not statistically significant (p=0.98). Conclusion. The efficacy of TXA and HQ was the same and both could significantly reduce MASI scores.

Tranexamic acid has no advantage in head and neck surgical procedures: a randomised, double-blind, controlled clinical trial

2019 ◽  
Vol 133 (12) ◽  
pp. 1024-1032
Author(s):  
A Thakur ◽  
S Gupta ◽  
J S Thakur ◽  
R S Minhas ◽  
R K Azad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tranexamic Acid ◽  
Head And Neck ◽  
Surgical Procedures ◽  
Primary Tumour ◽  
Blood Parameters ◽  
Controlled Clinical Trial ◽  
Skin Closure ◽  
Double Blind ◽  
The Difference

AbstractObjectiveTo assess the effect of tranexamic acid in head and neck surgical procedures.MethodsA prospective, double-blind and randomised, parallel group, placebo-controlled clinical trial was conducted. Ninety-two patients undergoing various head and neck surgical procedures were randomised. Subjects received seven infusions of coded drugs (tranexamic acid or normal saline) starting at the time of skin closure. Haematological, biochemical, blood loss and other parameters were observed by the staff, who were blinded to patients’ group allocation (case or control).ResultsPatients were analysed on the basis of type of surgery. Fifty patients who had undergone surgical procedures, including total thyroidectomy, total parotidectomy, and various neck dissections with or without primary tumour excision, were included in the first group. The second group comprised 41 patients who had undergone hemithyroidectomy, lobectomy or superficial parotidectomy. There was no statistical difference in blood parameters between both groups. There was a reduction in post-operative drain volume, but this was not significant.ConclusionAlthough this prospective, randomised, placebo-controlled clinical trial found a reduction in post-operative drain volume in tranexamic acid groups, the difference was not statistically significant between the various head and neck surgical procedure groups.

Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

2019 ◽  
Vol 14 (4) ◽  
pp. 286-291 ◽  
Author(s):  
Pouya Ebrahimi ◽  
Javad Mozafari ◽  
Reza Bahrami Ilkhchi ◽  
Mohammad Ghasem Hanafi ◽  
Maryam Mousavinejad
Keyword(s):  
Tranexamic Acid ◽  
Intracranial Hemorrhage ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Subdural Hemorrhage ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Epidural Hemorrhage ◽  
And Control

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED). Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery. Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well. Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P &lt; 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

Nebulized Budesonide Is as Effective as Nebulized Adrenaline in Moderately Severe Croup

PEDIATRICS ◽  
1996 ◽  
Vol 97 (5) ◽  
pp. 722-725
Author(s):  
Dominic Fitzgerald ◽  
Craig Mellis ◽  
Mark Johnson ◽  
Hugh Allen ◽  
Peter Cooper ◽  
...  
Keyword(s):  
Symptom Score ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Upper Airway ◽  
Primary Outcome Measure ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Duration Of Hospitalization

Objective. Nebulized budesonide and nebulized adrenaline have been shown to be effective in the treatment of moderately severe croup. However, there has been no direct comparison of these therapies. We undertook a multicenter, randomized, double-blind, parallel group study in 66 hospitalized children with viral or spasmodic croup. Methods. Children 0.5 to 6 years of age were assessed using a validated croup symptom score (stridor, 0 through 4; cough, 0 through 3; retractions, 0 through 3; dyspnea, 0 through 3; and color, 0 through 4) at 0.5, 1, 1.5, 2, 12, and 24 hours after nebulization. Patients received either budesonide (2 mg/4 mL) or L-adrenaline (4 mg/4 mL) via nebulization. The primary outcome measure was change in the total croup symptom score. Results. Thirty-five children received budesonide and 31 received adrenaline. There was no significant difference in baseline features, including croup score (mean [95% confidence interval]: budesonide, 7.1 [6.7- 7.5]; adrenaline, 7.7 [7.3-8.1]). All patients had significant improvement from baseline, and there was no significant difference between the two treatments, as measured by change in croup scores, change in oxygen saturation, duration of hospitalization, number of subsequent treatments with systemic steroids or adrenaline, and adverse events. No child required intubation. Conclusion. This study does not show any difference in efficacy and safety between nebulized budesonide and nebulized adrenaline in the treatment of acute upper airway obstruction in patients with moderately severe croup.

scholarly journals High- v. low-dose quetiapine in schizophrenia: meta-analysis

2010 ◽  
Vol 34 (1) ◽  
pp. 9-12 ◽  
Author(s):  
Nitesh Painuly
Keyword(s):  
Acute Treatment ◽  
Low Dose ◽  
Response Rate ◽  
Meta Analysis ◽  
Fixed Dose ◽  
Clinical Implications ◽  
Positive Symptoms ◽  
Double Blind ◽  
Significant Difference ◽  
The Difference

Aims and methodTo study the difference between high- and low-dose quetiapine in acute treatment of schizophrenia. Data available from published double-blind fixed-dose trials were combined and analysed.ResultsThere was no statistically significant difference between high- (750–800 mg/day) and low-dose (300–400 mg/day) quetiapine in terms of the response rate, change in positive symptoms score and the discontinuation rates either as a result of lack of response or adverse effects.Clinical implicationsCombined evidence from fixed-dose trials does not support the prevalent practice of targeting the higher dose of quetiapine for optimal treatment response in schizophrenia.

scholarly journals Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Miao Miao ◽  
Xian Xiao ◽  
Jiayi Tian ◽  
Yunzhi Zhufeng ◽  
Ruiling Feng ◽  
...  
Keyword(s):  
Low Dose ◽  
Activity Index ◽  
Cell Subset ◽  
Immunoglobulin M ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Immune Balance ◽  
Cell Balance ◽  
Post Hoc

Abstract Objective To investigate the regulation of T follicular regulatory (Tfr) and T follicular (Tfh) cell subtypes by low-dose IL-2 in systemic lupus erythematosus (SLE) in a randomized, double-blind, placebo-controlled clinical trial. Methods A post hoc analysis was performed in a randomized cohort of SLE patients (n=60) receiving low-dose IL-2 therapy (n=30) or placebo (n=30), along with the standard of care treatment. The primary endpoint was the attainment of SLE responder index-4 (SRI-4) at week 12 in the trial. Twenty-three healthy controls were enrolled for T cell subset detection at the same time as the trial. The t-stochastic neighbor embedding (tSNE) analysis of CD4 T subsets based on immune cells flow cytometry markers was performed to distinguish Tfh, Tfh1, Tfh2, Tfh17, and Tfr cell subsets. Results Compared with HC, the frequency of Tfr (CXCR5+PD-1low Treg and CXCR5+PD-1high Treg) cells was significantly reduced, while the pro-inflammatory Tfh cells were increased in patients with SLE. The imbalanced Tfh cell was associated with several pathogenic factors (anti-dsDNA antibodies (r=0.309, P=0.027) and serum IL-17 (r=0.328, P=0.021)) and SLE Disease Activity Index (SLEDAI) score (r=0.273, P=0.052). Decreased CXCR5+PD-1low Treg/Tfh and CXCR5+PD-1low Treg/Tfh17 were both associated with increased immunoglobulin M (IgM) (r=−0.448, P=0.002 and r=−0.336, P=0.024, respectively). Efficacy of low-dose IL-2 therapy was associated with a restored Tfr/Tfh cell balance. Conclusion These data support the hypothesis that promotion of Tfr is associated with decreased disease activities and that low-dose IL-2 therapy can recover Tfr/Tfh immune balance. Trial registration number ClinicalTrials.gov Registries (NCT02465580).

scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

INR Response to Low-Dose Vitamin K in Warfarin Patients

2021 ◽  
pp. 106002802199323
Author(s):  
Caitlin E. Kulig ◽  
A. Joshua Roberts ◽  
A. Shaun Rowe ◽  
Hahyoon Kim ◽  
William E. Dager
Keyword(s):  
Vitamin K ◽  
Primary Outcome ◽  
Low Dose ◽  
International Normalized Ratio ◽  
Mortality Rates ◽  
Observational Cohort Study ◽  
Significant Difference ◽  
Observational Cohort ◽  
Reduction Effect ◽  
Retrospective Observational Cohort Study

Background Literature suggests that 2 mg of vitamin K intravenously (IV) provides a similar effect as 10 mg to reverse warfarin. Doses <5 mg haven’t been studied in depth. Objective The objective was to determine the international normalized ratio (INR) reduction effect of ultra low-dose (ULD) IV vitamin K. Methods This retrospective, observational cohort study compared IV vitamin K doses of 0.25-0.5 mg (ULD) versus 1-2 mg (standard low dose [SLD]). The primary outcome assessed ΔINR at 36 hours; secondary outcomes assessed ΔINR at 12 hours and 30-day venous thromboembolism (VTE) and mortality rates. Results Of 88 patients identified (median baseline INR [IQR], 5.1 [3.1, 7.3] vs 4.5 [2.8, 8.2], ULD vs SLD, respectively), 59 had an INR at 12 hours. The ULD had fewer 12-hour INR values <2, with no statistical difference in the ΔINR at 12 hours between the ULD and SLD cohorts (median ΔINR, 2.2 [1.1, 3.4] vs 2.2 [1.1, 6.3]; P = 0.54; median INR, 2.3 vs 1.8). A total of 41 patients had both a 12- and 36-hour INR. No significant difference in the ΔINR between the 12- and 36-hour values occurred (median ΔINR, 0.52 [0.2, 0.91] vs ΔINR, 0.46 [0.18, 0.55]; P = 0.61), suggesting no rebound or excessive reversal and no difference in 30-day rates of VTE ( P > 0.99) or death ( P = 0.38). Conclusion and Relevance ULD IV vitamin K reversed INR similarly to doses of 1-2 mg without rebound. A ULD strategy may be considered in patients requiring more cautious reversal.

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

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