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Pharmacokinetic Study of Tranexamic Acid

NCT ID: NCT06728670

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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The investigators plan to recuit 30 patients, administered TXA through different routes of administration. Then Pharmacokinetic parameters of different TXA administration routes were recorded. To study the effects of different TXA administration routes on intraoperative blood loss, transfusion volume and postoperative adverse outcomes (thrombosis, etc.) in ovarian cancer patients undergoing cell reduction surgery.

Conditions

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Ovarian Neoplasm Epithelial

Keywords

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Tranexamic acid pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intravenous TXA injection group and intramuscular TXA injection group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intravenous infusion of TXA

Slowly infuse 1g TXA at a rate of approximately 1 ml/min.

Group Type ACTIVE_COMPARATOR

Tranexamic acid Intravenous Infusion

Intervention Type BEHAVIORAL

A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.

Intramuscular injection of TXA

1g TXA is administered with twice intramuscular injections, and each injection takes no more than 30 seconds. The injection site is chosen as the deltoid or lateral thigh muscle.

Group Type EXPERIMENTAL

TXA intramuscular injection

Intervention Type BEHAVIORAL

5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle

Interventions

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Tranexamic acid Intravenous Infusion

A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.

Intervention Type BEHAVIORAL

TXA intramuscular injection

5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adult women aged 20-64 diagnosed with advanced ovarian cancer undergoing cytoreductive surgery
2. The cancer stage is III-IV
3. ASA classification II-III
4. Surgical duration\>2 hours

Exclusion Criteria

1. Renal dysfunction (serum creatinine\>200 mmol/L) or liver dysfunction (Child Turcote classification\>6)
2. Has a history of serious mental illness or disorders, epilepsy, visual impairment
3. Previous or current bleeding disorders, coagulation dysfunction, or thromboembolic events
4. Lower limb venous thrombosis
5. Anticoagulants or antifibrinolytic drugs used before surgery within the past month
6. Allergic to TXA
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhu Yejing

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yejing Zhu, PHD

Role: CONTACT

Phone: 86+18758096745

Email: [email protected]

Facility Contacts

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Yejing Zhu, PHD

Role: primary

References

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CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

Reference Type RESULT
PMID: 20554319 (View on PubMed)

Vergote I, Coens C, Nankivell M, Kristensen GB, Parmar MKB, Ehlen T, Jayson GC, Johnson N, Swart AM, Verheijen R, McCluggage WG, Perren T, Panici PB, Kenter G, Casado A, Mendiola C, Stuart G, Reed NS, Kehoe S; EORTC; MRC CHORUS study investigators. Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials. Lancet Oncol. 2018 Dec;19(12):1680-1687. doi: 10.1016/S1470-2045(18)30566-7. Epub 2018 Nov 6.

Reference Type RESULT
PMID: 30413383 (View on PubMed)

Other Identifiers

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IRB-2024-1034

Identifier Type: -

Identifier Source: org_study_id