Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer

NCT04360629CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Jun Zhang

Enrollment

151

Start Date

2020-06-03

Completion Date

2021-12-30

Study Type

INTERVENTIONAL

Official Title

Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer

Interventions

Tranexamic Acidnormal saline

Conditions

Advanced Ovarian Cancer

Eligibility

Age Range

20 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

1. sign the informed consent
2. Aged 20-70 years
3. ovarian cancer patients, staged IIIB - C or above

3\) ASA I - II

Exclusion Criteria:

1. tranexamic acid allergy
2. pregnancy and lactation
3. only lymph node metastasise
4. history of mental disorder, immune system disorder
5. history of epilepsy, dyschromatopsia
6. arrhythmia
7. history of renal insufficiency
8. thrombosis related disease
9. Hb \< 90 g/dL
10. using anticoagulant drugs (not including aspirin discontinuation 1 week
11. having participated in other clinical trials, or refusing to join the research.

Outcome Measures

Primary Outcomes

operative and postoperative blood loss

the amount of bleeding

Time frame: up to 8 days

Locations

Shanghai Cancer Center, Fudan University, Shanghai, China

Linked Papers

2023-04-07

Intraoperative use of tranexamic acid to reduce blood loss during cytoreductive surgery for advanced ovarian cancer: A randomized controlled clinical trial

AbstractIntroductionTranexamic acid reduces blood loss and allogeneic transfusion requirements in various surgical procedures. The role of tranexamic acid during cytoreductive procedures in advanced ovarian cancer is not clear.Material and methodsThis was a single center randomized, controlled, three‐armed clinical trial. A total of 150 ovarian cancer patients undergoing cytoreductive surgery were recruited and assigned to three groups (n = 50/group): the control group (normal saline), low‐dose group (10 mg/kg bolus + 1 mg/kg continuous infusion of tranexamic acid), and high‐dose group (20 mg/kg bolus + 5 mg/kg continuous infusion of tranexamic acid). The primary endpoint was intraoperative blood loss volume and total blood loss volume, and secondary endpoints included intraoperative blood transfusion volumes, vasoactive agent consumption, admission into the intensive care unit, and incidence of postoperative complications within postoperative 30 days. The study was registered at ClinicalTrials.gov ID: NCT04360629.ResultsThe patients in the high‐dose group had less intraoperative (median [IQR]: 625.3 mL [343.5–1210.5]) and total blood loss volume (748.9 mL [292.2–1650.2]) than those in the control group (1015.5 mL [679.4–1015.5], p = 0.012; and 1700.7 mL [458.7–2419.8], p = 0.004, respectively). In contrast, the intraoperative (992.5 mL [539.0–1404.0], p = 0.874) and total blood loss volume (1025.0 mL [381.8–1819.9], p = 0.113) was not significantly reduced in the low‐dose group when compared with the control group. Correspondingly, the relative risk of blood transfusion (RR [95% CI], 0.405 [0.180–0.909], p = 0.028) was reduced in the high‐dose group and required less intraoperative noradrenaline (881.0 ± 438.3 mg) to maintain stable hemodynamics than the control group (1548.0 ± 349.8 mg, p = 0.001). Furthermore, compared with the control group, the two tranexamic acid groups had decreased intensive care unit admission rates (p = 0.016) without increasing the incidence of postoperative seizure, acute kidney injury, and thromboembolism.ConclusionsHigh‐dose tranexamic acid is more effective in reducing blood loss and blood transfusion without increasing the risk of postoperative complications. The high‐dose regime tended to have a better risk–benefit profile.

Linked Investigators