| Registry | NCT04360629 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 151 (Actual) |
| Sponsor | Jun Zhang (Other) |
| Conditions | Advanced Ovarian Cancer |
| Interventions | Tranexamic Acid, normal saline (Drug) |
| Dates | start 2020-06-03, primary completion 2021-12-30, completion 2021-12-30, first posted 2020-04-24, last updated 2022-06-01 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Advanced Ovarian Cancer All trials of Tranexamic Acid All trials of normal saline
Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated.
In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations.
In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.
We performed a single blind, prospective, randomised control trial (RCT) . The patients randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline which will be infused prior to skin incision in patients undergoing elective cytorsductive surgery for ovarian cancer .
Intraoperative blood loss will be estimated by the volume in the suction drains and by weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.
The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30 days, 30-day all-cause readmission and so on.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| high dose TXA | Experimental | Drug: Tranexamic Acid | TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol |
| low dose TXA | Experimental | Drug: Tranexamic Acid | TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol |
| normal saline | Placebo comparator | Drug: normal saline | saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg |
Sex: Female, ages: 20 Years to 70 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Cancer Center, Fudan University | Shanghai, Shanghai Municipality | China |