Topical tranexamic acid delivered as a mist before chest closure reduced postoperative drainage and red-cell transfusion exposure in a small randomized study of elective on-pump coronary artery bypass grafting (CABG). Jagadish and colleagues compared 2 g of topical tranexamic acid (TXA) with saline mist in 60 patients. The findings support further evaluation of this local antifibrinolytic approach, but do not establish superiority to intravenous TXA or exclude uncommon adverse events.
Why Study Topical Tranexamic Acid?
Bleeding after cardiopulmonary bypass can reflect surgical bleeding, platelet dysfunction, coagulation disturbances, and fibrinolysis. TXA inhibits fibrin breakdown by interfering with plasminogen and plasmin binding to fibrin. Applying it directly to surgical surfaces aims to concentrate its action locally.
The study tested a method of topical delivery rather than comparing all possible antifibrinolytic strategies. A localized route should not be assumed to eliminate systemic absorption or prove a lower seizure or thrombosis risk. Those questions require appropriate pharmacokinetic measurements and much larger safety comparisons.
Trial Design and Patient Selection
This prospective, single-center, double-blinded randomized trial was conducted in Manipal, India, during 2022–2024. Sixty-two patients were assessed, and two were excluded after their procedures changed to combined CABG and mitral surgery. The remaining 60 patients were allocated equally to TXA or saline.
The authors describe computer-generated randomization, sealed opaque allocation envelopes, and study-drug preparation by a nursing officer outside the study. Patients, the surgeon, anesthesia provider, and postoperative observers were reported to be blinded.
Eligible patients were 40–75 years old and undergoing elective on-pump CABG. Exclusions included prior surgery, emergency procedures, known TXA allergy, significant coagulopathy, serum creatinine above 2 mg/dL, and left ventricular ejection fraction below 35%. The results therefore have limited applicability to redo, emergency, renally impaired, or severely ventricular-impaired populations.
How the Mist Was Applied
After separation from bypass and reversal of heparin with protamine, the surgeon applied either 2 g TXA or 20 mL normal saline as a mist before sternal closure. Application covered the pericardium, left internal mammary artery harvest bed, and sternotomy surfaces. The report describes a mister-blower supplied through an infusion pump with an oxygen source.
This is a description of the investigators’ protocol, not a validated universal dosing or device-use instruction. The trial did not compare mist with another topical method, and it does not clearly establish the incremental benefit of mist when added to a standardized contemporary intravenous TXA regimen.
Drainage, Transfusion, and Ventilation Results
The principal endpoint was drainage over 48 hours. The study also assessed transfusion exposure and early postoperative outcomes.
| Outcome | Topical TXA (n=30) | Saline control (n=30) |
|---|---|---|
| Mean 24-hour drainage | 213.67 ± 96.63 mL | 480 ± 302.41 mL |
| Mean 48-hour drainage | 302.41 ± 95.53 mL | 582.5 ± 252.93 mL |
| Patients receiving packed red cells | 4 (13.3%) | 13 (43.3%) |
| Mean mechanical ventilation duration | 7.1 ± 3.19 hours | 10.1 ± 3.68 hours |
| Re-exploration for bleeding/tamponade | 0 | 1 |
The difference in mean 48-hour drainage was approximately 280 mL. The absolute difference in red-cell exposure was 30 percentage points in this sample. Platelet and fresh-frozen plasma requirements did not differ significantly, so the findings should not be summarized as a proven reduction in every blood product.
The paper gives inconsistent P values for transfusion across the abstract, Results, and Discussion. This summary prioritizes the explicit patient counts and the Results section rather than presenting all reported significance values as interchangeable. The shorter ventilation duration is a secondary finding; the trial does not demonstrate that reduced drainage caused earlier extubation.
How Transfusion Practice Affects Interpretation
Transfusion decisions considered hemoglobin below 9 g/dL, bleeding rate, and hemodynamic status, as judged by the surgeon. This contextual threshold matters: transfusion exposure can change when institutions use different triggers or blood-management pathways.
The study reports broadly comparable operative characteristics, including pump and cross-clamp times. Nevertheless, a sample of 30 patients per group cannot ensure complete balance in every prognostic factor. The effect size should be confirmed in larger trials using clearly specified background antifibrinolytic and transfusion protocols.
What the Safety Results Can Show
No seizures, stroke, ST-segment elevation, or thromboembolic events were reported in either group during the observed period. The Discussion also reports no renal failure. These observations are useful, but an absence of events among 60 selected patients does not establish that the treatment has no such risks.
The study did not establish long-term graft patency, delayed thrombotic outcomes, systemic TXA concentrations, or comparative safety against intravenous treatment. Nor can one control-group re-exploration establish a reliable reduction in reoperation risk.
Relevance for Perfusion and Blood-Management Teams
The intervention took place after CPB and protamine, placing it within a coordinated surgical, anesthesia, and perfusion blood-management pathway. Topical antifibrinolysis addresses fibrin breakdown at treated surfaces; it does not replace assessment of surgical hemostasis, residual anticoagulation, platelet function, or coagulation deficits.
For teams evaluating this approach, the research question is whether local delivery adds clinically meaningful benefit to an explicit baseline blood-management strategy. The present trial offers an encouraging efficacy signal in selected elective CABG patients, while leaving the best delivery method, background systemic regimen, and rare-event safety unresolved.
Limitations and Disclosures
This was a small single-center trial focused on short-term outcomes. High-risk exclusions restrict generalizability, and reporting inconsistencies in significance values and sample-size assumptions warrant caution. The study compared TXA mist with saline mist, rather than directly testing topical versus intravenous TXA or mist versus another topical application method.
The study was registered with the Clinical Trial Registry of India (CTRI/2023/05/052353) and received institutional ethics approval. The authors report funding through a postgraduate research grant and no conflicts of interest.
Original Article
Jagadish C, Kumara V, Aspari MA, Rai DG, Sumanth R. A comparative study of the efficacy and safety profile of topical application of tranexamic acid in the form of mist to reduce postoperative bleeding in on-pump CABG procedures. Annals of Cardiac Anaesthesia. 2025;28:287–291. doi:10.4103/aca.aca_176_24.
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