ArticleTrials2018
Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02797119 (Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Tranexamic acid for preventing postpartum haemorrhage after vaginal birth.The Cochrane database of systematic reviews · 2025Pooled it
- Tranexamic acid for preventing postpartum haemorrhage after caesarean section.The Cochrane database of systematic reviews · 2024Pooled it
- Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study.British journal of anaesthesia · 2022Trial
- Management of pregnant female with Haemophilia-A: A case report.Journal of family medicine and primary care · 2022Article
- Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery.Pharmaceutics · 2022Article
- Traces pilot pharmacokinetic study dataset.Data in brief · 2020Article
- A Comparison Study of Chaihu Shugan San and Fluoxetine on Antidepression and Regulating Blood Rheology Effects with Chronic Restrained Stress Rats.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Comparison of the Effect of Intravenous Tranexamic Acid and Sublingual Misoprostol on Reducing Bleeding After Cesarean Section: A Double-Blind Randomized Clinical Trial.Journal of obstetrics and gynaecology of India · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundPostpartum haemorrhage (PPH) is the leading cause of maternal death worldwide. Tranexamic acid (TA), an antifibrinolytic drug, reduces bleeding and transfusion need in major surgery and trauma. In ongoing PPH following vaginal delivery, a high dose of TA decreases PPH volume and duration, as well as maternal morbidity, while early fibrinolysis is inhibited. In a large international trial, a TA single dose reduced mortality due to bleeding but not the hysterectomy rate. TA therapeutic dosages vary from 2.5 to 100 mg/kg and seizures, visual disturbances and nausea are observed with the highest dosages. TA efficiency and optimal dosage in haemorrhagic caesarean section (CS) has not been yet determined. We hypothesise large variations in fibrinolytic activity during haemorrhagic caesarean section needing targeted TA doses for clinical and biological efficacy. METHODS/
designThe current study proposal is a blinded, randomised controlled trial with the primary objective of determining superiority of either 1 g of TXA or 0.5 g of TXA, in comparison to placebo, in terms of 30% blood-loss reduction at 6 h after non-emergency haemorrhagic caesarean delivery (active PPH > 800 mL) and to correlate this clinical effect in a pharmacokinetics model with fibrinolysis inhibition measured by an innovative direct plasmin measurement regarding plasmatic TA concentration. A sample size of 342 subjects (114 per group) was calculated, based on the expected difference of 30% reduction of blood loss between the placebo group and the low-dose group, out of which 144 patients will be included blindly in the pharmaco-biological substudy. A non-haemorrhagic reference group will include 48 patients in order to give a reference for peak plasmin level. DISCUSSION: TRACES trial is expected to give the first pharmacokinetics data to determinate the optimal dose of tranexamic acid to reduce blood loss and inhibit fibrinolysis in hemorrhagic cesarean section.
trial registrationClinicalTrials.gov, ID: NCT02797119 . Registered on 13 June 2016.
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