scholarly journals Is low dose Tranexamic acid less effective than a standard dose at reducing blood loss and inhibiting hyperfibrinolysis in hemorrhagic caesarean section? Multicenter double–blind placebo-controlled dose-ranging (TRACES) trial.

2021 ◽  
Author(s):  
Anne-Sophie Ducloy-Bouthors ◽  
Sixtine Gilliot ◽  
Maeva Kyheng ◽  
David Faraoni ◽  
Alexandre Turbelin ◽  
...  
Keyword(s):  
Caesarean Section ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Standard Dose ◽  
Study Drug ◽  
Double Blind ◽  
Simultaneous Generation ◽  
Pharmacodynamic Modelling ◽  
Dose Ranging ◽  
To Receive

Objective: To study the effect of a low (0.5g) or a standard (1g) tranexamic acid (TA) dose compared to placebo on clinical and biological endpoints in women experiencing postpartum hemorrhage (PPH) Design: TRACES trial is a double-blind, randomized, placebo-controlled, dose-ranging study Setting: 8 women hospitals in France. Population: Women experiencing PPH > 800 mL during caesarean section. Method: After informed consent, patients were randomized to receive either TA 0.5g (n=57), TA 1g (n=58), or a placebo (n=60). Data were collected at 8 time-points. Main outcome measures: Efficacy: additional blood loss after study drug, maternal morbidity, safety, biology: D-dimers, plasmin-antiplasmin complexes (PAP), simultaneous-generation-thrombin-plasmin-potential. Results: Compared to 1g dose, 0.5g TA was less effective to reduce additional blood loss (300 mL [95% confidence interval (95%CI) 68 to 630] vs 134 mL [95%CI50 to 419] (p=0.042)). Compared to placebo, 1g TA, but not 0.5g, inhibited hyperfibrinolysis as shown by plasmin generation potential, % increase in D-dimers from injection to 120 minutes (93% [95%CI 68 to 118] vs 58% [ 95%CI 32 to 84] (p=0.06) vs 38% [95%CI 13 to 63] (p=0.003) and % increase in PAP from injection to 30 minutes (56% [95%CI 25 to 87] vs 13% [ 95%CI 18 to 43] (p=0,051) vs -2% [95%CI -32 to 28] (p=0.009)). Conclusions: In this study, fibrinolysis inhibition was more sustained after the administration of 1g TA compared to 0.5g TA or a placebo. Further pharmacokinetic-pharmacodynamic modelling will be needed to determine the optimal TA dose to be administered in PPH. NCT 02797119

Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications

2019 ◽  
Vol 31 (2) ◽  
pp. 194-200 ◽  
Author(s):  
Signe Elmose ◽  
Mikkel Ø. Andersen ◽  
Else Bay Andresen ◽  
Leah Yacat Carreon
Keyword(s):  
Placebo Group ◽  
Lumbar Spine ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Spine Surgery ◽  
Operative Time ◽  
Decompressive Surgery ◽  
Lumbar Spine Surgery ◽  
Intraoperative Blood Loss ◽  
Double Blind

OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

scholarly journals Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplastyA prospective randomized double-blind study in 40 patients

2003 ◽  
Vol 74 (6) ◽  
pp. 665-669 ◽  
Author(s):  
Henrik Husted ◽  
Lars Blønd ◽  
Stig Sonne-Holm ◽  
Gitte Holm ◽  
Tine Jacobsen ◽  
...  
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Blind Study ◽  
Blood Transfusions ◽  
Double Blind Study ◽  
Double Blind ◽  
Total Hip

A phase III, randomized, double-blind, multicenter, active control study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC): CONSOLE.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12099-12099
Author(s):  
Yoshimasa Shiraishi ◽  
Akito Hata ◽  
Naoki Inui ◽  
Morihito Okada ◽  
Masahiro Morise ◽  
...  
Keyword(s):  
Study Drug ◽  
Incidence Rates ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Secondary Endpoints ◽  
To Receive ◽  
Age Category

12099 Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity for the neurokinin-1 (NK-1) receptor and a long half-life of 70 h. This phase 3 study is the first head-to-head study to compare two NK-1 receptor antagonists, FN and fosaprepitant (FA), in combination with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (JapicCTI-194611). Methods: Patients scheduled to receive cisplatin (≥70 mg/m2) -based chemotherapy were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg, in combination with palonosetron 0.75 mg and dexamethasone (9.9 mg on day 1, 6.6 mg on days 2-4). The stratification factors were sex, age category (<55 vs. ≥55 years), and site. The primary endpoint was the complete response (CR; no emetic events and no rescue medication) rate, stratified by sex and age category, during the overall phase (0-120 h) to show the non-inferiority (margin, -10%) of FN to FA. The secondary endpoints were: CR rate, complete protection rate, total control rate, no nausea rate, no emetic events rate in each period [i.e., acute (0-24 h), delayed (24-120 h), overall, 0-168 h and 120-168 h], time to treatment failure, and safety, including injection site reactions (ISRs). Assessment of efficacy was continued until 168 h after the initiation of cisplatin. Some eligible patients were evaluated for safety and efficacy of FN for up to four cycles. Results: Between February 2019 and March 2020, total 795 patients were enrolled in the study. The study drug was administered to 785 patients (n=392 in FN vs. n=393 in FA), and all of them were evaluated for efficacy and safety. Baseline characteristics were generally balanced between the two groups. The adjusted overall CR rate was 75.2% in FN vs. 71.0% in FA [MH common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), thus demonstrating non-inferiority of FN to FA. Regarding the other secondary endpoints of efficacy until 168 h, FN was favorable against FA, especially the CR rate during 0-168 h (73.2% in FN vs. 66.9% in FA) (Table). The incidence rates of treatment-related adverse events were 22.2% in FN vs. 25.4% in FA, whereas those of ISRs with any cause or with treatment-related were 11.0% or 0.3% in FN vs 20.6% or 3.6% in FA, respectively ( p<0.001). Conclusions: FN demonstrated non-inferiority to FA, with a favorable safety profile and lower risk for ISRs. For the period beyond 120 h after initiation of chemotherapy, FN may have the potential to improve the prevention of “beyond delayed” CINV. Clinical trial information: JapicCTI-194611. [Table: see text]

scholarly journals High-Dose Adrenaline in Adult In-Hospital Asystolic Cardiopulmonary Resuscitation: A Double-Blind Randomised Trial

1993 ◽  
Vol 21 (2) ◽  
pp. 192-196 ◽  
Author(s):  
J. Lipman ◽  
W. Wilson ◽  
S. Kobilski ◽  
J. Scribante ◽  
C. Lee ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Arrest ◽  
Intensive Care ◽  
Side Effects ◽  
Cardiopulmonary Resuscitation ◽  
Standard Dose ◽  
Randomised Trial ◽  
High Dose ◽  
Double Blind ◽  
To Receive

Forty intensive care unit patients requiring cardiopulmonary resuscitation were randomised to receive either the standard dose of adrenaline (1 mg every five minutes) or high-dose adrenaline (10 mg every five minutes). In the majority of patients, overwhelming sepsis was the major contributing factor leading to cardiac arrest. In this group of patients no difference could be detected in response to high-dose adrenaline compared with the standard dose. Although no side-effects were noted with this high dose of adrenaline, more investigation is required prior to its routine use in cardiopulmonary resuscitation.

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