Trial reportJournal of cardiothoracic surgery2020
Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up.
Trial report in Journal of cardiothoracic surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01060189 (Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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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.
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Effects of interventions targeting the systemic inflammatory response to cardiac surgery on clinical outcomes in adults.The Cochrane database of systematic reviews · 2023Pooled it
- The effect of Ulinastatin on postoperative course in cardiopulmonary bypass patients in Asia: a meta-analysis of randomized controlled trials.Journal of cardiothoracic surgery · 2022Pooled it
- Neither tranexamic acid nor ulinastatin affects the activated clotting time values in healthy volunteers and heparinized cardiovascular surgery patients.Journal of cardiothoracic surgery · 2026Article
- Effects of different doses of ulinastatin on organ protection of deep hypothermic circulatory arrest in rats.Journal of cardiothoracic surgery · 2025Article
- Inflammatory risk stratification individualizes anti-inflammatory pharmacotherapy for acute type A aortic dissection.Innovation (Cambridge (Mass.)) · 2023Article
- Ulinastatin in combination with aprotinin improves systemic inflammation in patients undergoing cardiac surgery with cardiopulmonary bypass.American journal of translational research · 2023Article
- Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMajor bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
methodsIn this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
resultsCompared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
conclusionsUlinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
trial registrationThe trial was retrospectively registered on February 2, 2010. TRIAL REGISTRATION NUMBER: https://www.clinicaltrials.gov Identifier: NCT01060189.
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