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Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.

ABSTRACT: BACKGROUND:Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding. METHODS:This was a two-centre, stratified, parallel-group, placebo-controlled, double-blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1?:?1 to moistening of wound surface before closure with either 25?mg/ml TXA or 0·9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24?h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3?months. RESULTS:Between 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24?h (110 versus 144?ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089). CONCLUSION:Moistening the wound with TXA 25?mg/ml before closure reduces postoperative bleeding within the first 24?h in patients undergoing mastectomy. Registration number: NCT02627560 (https://clinicaltrials.gov).

SUBMITTER: Ausen K

PROVIDER: S-EPMC7093788 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.

Ausen K K Hagen A I AI Østbyhaug H S HS Olafsson S S Kvalsund B J BJ Spigset O O Pleym H H

BJS open 20191226 2

<h4>Background</h4>Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding.<h4>Methods</h4>This was a two-centre, stratified, parallel-group, placebo-controlled, double-blind RCT. Patients undergoing mastectomy with or ...[more]

PMID: 32207575

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Project description:BackgroundGlanzmann thrombasthenia is a rare bleeding disorder due to defects in the glycoprotein Ilb/IIIa complex present on the platelet membrane. The most common mode of treatment for this disorder is platelet transfusion. However, scientific evidence does state that repeated transfusions could lead to auto immunization making transfusions ineffective.Aim and objectiveTo describe the use of a novel technique of soft splint with tranexamic acid paste to stop oral bleeding in a patient with Glanzmann thrombasthenia (GT).Case descriptionA 7-year-old female patient with a known history of GT was referred to the pediatric department. The chief complaint of the patient revealed a history of spontaneous bleeding from the oral cavity. The patient required multiple teeth extractions due to severely carious teeth. History revealed that the patient was admitted to the hospital (casualty) three times within 1 month due to a similar complaint leading to hypovolemic shock. Several transfusion procedures were done to stop the spontaneous bleeding. To stop the intraoral bleeding without transfusions, a novel method of using a soft splint with tranexamic acid paste (500 mg tablet crushed and mixed with saline) in the area of spontaneous bleeding was employed with a successful follow-up of 7 months.ConclusionSoft splint with the tranexamic acid paste can serve as an effective method of treatment for patients with spontaneous oral bleeding due to medical conditions like GT.Clinical relevanceThis case report highlights the need for awareness among all the healthcare providers about the importance of regular dental visits. The healthcare providers also need to emphasize the same to all patients with medical conditions to avoid such life-threatening situations.How to cite this articleBhavyaa R, Vignesh KC, Muthu MS, et al. Glanzmann Thrombasthenia: Use of the Soft Splint with Tranexamic Acid Paste to Reduce Spontaneous Oral Bleeding. Int J Clin Pediatr Dent 2021;14(4):580-585.

Project description:BackgroundTotal knee arthroplasty (TKA) is associated with a significant blood loss. Several methods have been reported to reduce postoperative blood loss and avoid homologous blood transfusions. In this study, we investigated the efficacy of temporary clamping of the drain either or not in combination with tranexamic acid administration for controlling blood loss after TKA.MethodsThe prospective, randomized, and double-blinded study was conducted in our institute. Total of 240 patients, who diagnosed primary osteoarthritis and scheduled to undergo a primary TKA,,were randomized into one of the four groups: Group A or control group, the drain was not clamped and the patient received a placebo; Group B, the drain was not clamped and the patient received tranexamic acid; Group C, the drain was clamped and the patient received a placebo; and Group D, the drain was clamped and the patient received tranexamic acid. The volume of drained blood at 48 hours postoperatively, the decreasing of hemoglobin (Hb) level at 12 hours postoperatively and the number of patients requiring blood transfusion were recorded and compared.ResultsThe mean postoperative volumes of drained blood and the amount of blood transfusion in the three study groups (group B, C and D) were significantly lower than those in the control group (p < 0.05), which group D had the lowest values. Furthermore, group B and D could maintain the Hb level better than group A and C (p < 0.001). In terms of blood transfusions rate, although the patients in group D required transfusion less than group A and C (p < 0.05), there was no significant difference between group D and B. The relative risks for transfusion requirement were 4.4 for group A, 1.4 for group B and 3.0 for group C when compared to group D.ConclusionsThe clamping of drain combined with tranexamic acid administration could reduce postoperative blood loss and blood transfusion after TKA, significantly greater than using tranexamic acid or drain clamping alone.Trial registrationClinicalTrials.gov NCT01449552.

Project description:BackgroundOral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem. We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with NOACs.Methods and findingsThe EXTRACT-NOAC study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients were randomly assigned to 10% TXA or placebo mouthwash and were instructed to use the mouthwash once prior to dental extraction, and thereafter for 3 times a day for 3 days. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes included periprocedural, early, and delayed bleeding, and the safety outcomes included all thrombotic events. The first patient was randomized on February 9, 2018 and the last patient on March 12, 2020. Of 222 randomized patients, 218 patients were included in the full analysis set, of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P = 0.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P = 0.07). TXA did not reduce the rate of periprocedural bleeding (bleeding score 4 ± 1.78 versus 4 ± 1.82, P = 0.80) and early bleeding (rate ratio, 0.76; 95% CI, 0.42 to 1.37). Delayed bleeding (rate ratio, 0.32; 95% CI, 0.12 to 0.89) and bleeding after multiple extractions (rate ratio, 0.40; 95% CI, 0.20 to 0.78) were lower in the TXA group. One patient in the placebo group had a transient ischemic attack while interrupting the NOAC therapy in preparation for the dental extraction. Two of the study limitations were the premature interruption of the trial following a futility analysis and the assessment of the patients' compliance that was based on self-reported information during follow-up.ConclusionsIn patients on NOACs undergoing dental extraction, TXA does not seem to reduce the rate of periprocedural or early postoperative oral bleeding compared to placebo. TXA appears to reduce delayed bleeds and postoperative oral bleeding if multiple teeth are extracted.Trial registrationClinicalTrials.gov NCT03413891 EudraCT; EudraCT number:2017-001426-17; EudraCT Public website: eudract.ema.europa.eu.

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Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.

Publications

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.

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