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

Advanced Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360629
• Other study ID #: V1.0
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Tranexamic Acid
Tranexamic Acid will be given through central vein
• normal saline
normal saline will be given through central vein

Locations

Country	Name	City	State
China	Shanghai Cancer Center, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jun Zhang

Country where clinical trial is conducted

China, 

References & Publications (4)

Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793. — View Citation

Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P. Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 23;(1):CD011732. doi: 10.1002/14651858.CD011732. — View Citation

Lundin ES, Johansson T, Zachrisson H, Leandersson U, Bäckman F, Falknäs L, Kjølhede P. Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study. Acta O — View Citation

Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative and postoperative blood loss	the amount of bleeding	up to 8 days