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

Sponsor
Jun Zhang (Other)
Overall Status
Completed
CT.gov ID
NCT04360629
Collaborator
(none)
151
1
3
18.9
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Drug: normal saline
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
Actual Study Start Date :
Jun 3, 2020
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: high dose TXA

TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol

Drug: Tranexamic Acid
Tranexamic Acid will be given through central vein

Experimental: low dose TXA

TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol

Drug: Tranexamic Acid
Tranexamic Acid will be given through central vein

Placebo Comparator: normal saline

saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg

Drug: normal saline
normal saline will be given through central vein

Outcome Measures

Primary Outcome Measures

  1. operative and postoperative blood loss [up to 8 days]

    the amount of bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. sign the informed consent

  2. Aged 20-70 years

  3. ovarian cancer patients, staged IIIB - C or above

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Cancer Center, Fudan University Shanghai Shanghai China 200040

Sponsors and Collaborators

  • Jun Zhang

Investigators

  • Principal Investigator: Jun Zhang, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jun Zhang, Director of the department of anaesthesiology, Shanghai cancer center, Fudan University
ClinicalTrials.gov Identifier:
NCT04360629
Other Study ID Numbers:
  • V1.0
First Posted:
Apr 24, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022