NCT06728670Recruiting
Pharmacokinetic Study of Tranexamic Acid
Pharmacokinetic Study and Clinical Efficacy Observation of Different Routes of Tranexamic Acid Infusion in Advanced Ovarian Cancer Cell Reduction Surgery
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Tranexamic acid is an effective anti fibrinolytic drug. Clinical studies have found that intravenous injection of tranexamic acid is more effective in reducing blood loss and transfusion in patients with advanced ovarian cancer, without increasing the risk of postoperative complications. Different surgeries and administration routes have an impact on the pharmacokinetics and pharmacodynamics of TXA. At present, there is little data on the pharmacokinetics of intramuscular injection of TXA, and almost all of the data comes from males. For ovarian cancer patients, there are currently no reports on the pharmacokinetics of TXA through different routes of administration, such as intramuscular and intravenous administration. Therefore, the investigators chose ovarian cancer patients and administered it through different routes of intravenous and intramuscular injection.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Nov 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Zhejiang Cancer Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT06728670
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 20 Nov 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current bleeding disorders, coagulation dysfunction, or thromboembolic events
- Anticoagulants or antifibrinolytic drugs used before surgery within the past month
Other illness
- Has a history of serious mental illness or disorders, epilepsy, visual impairment
- Lower limb venous thrombosis
- Allergic to TXA
Lab values
- Renal dysfunction (serum creatinine\>200 mmol/L) or liver dysfunction (Child Turcote classification\>6)
Who the study is looking for
- Adult women aged 20-64 diagnosed with advanced ovarian cancer undergoing cytoreductive surgery
- The cancer stage is III-IV
- ASA classification II-III
- Surgical duration\>2 hours
Age in the registry: 20 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.