Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

Last updated: May 22, 2024
Sponsor: Acibadem University
Overall Status: Completed

Phase

N/A

Condition

Uterina Myoma

Sarcoma (Pediatric)

Hemorrhage

Treatment

Saline

Tranexamic acid

Clinical Study ID

NCT05517590
ATADEK-2022/05-33
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy volunteer female patients over the age of 18 who will undergo laparoscopicmyomectomy in our clinic will be included in our study.

Exclusion

Exclusion Criteria:

  1. Patients who are planned to undergo different surgery along with myomectomy

  2. Those with a diagnosis and suspicion of malignancy

  3. Those with a history of thromboembolic disease

  4. Those with cardiac, hepatic or renal disease

  5. Those with a body mass index of 30 and above

  6. Patients with abnormal coagulation test results

  7. Patients using anticoagulants

  8. Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5mg/dL)

  9. Those allergic to tranexamic acid

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Saline
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
April 30, 2024

Study Description

Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

Connect with a study center

  • Acibadem Maslak Hospital

    Istanbul, Sariyer 34457
    Turkey

    Site Not Available

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