Skip to main content
OpenTrials
Completed

NCT Number: NCT05517590

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who are planned to undergo different surgery along with myomectomy
  • Those with a diagnosis and suspicion of malignancy
  • Those with a history of thromboembolic disease
  • Those with cardiac, hepatic or renal disease
  • Those with a body mass index of 30 and above
  • Patients with abnormal coagulation test results
  • Patients using anticoagulants
  • Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL)
  • Those allergic to tranexamic acid

Treatment and study plan

Tranexamic Acid

Drug

1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Other names: Group I

Saline

Drug

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Other names: Group II

Primary outcomes

  1. Perioperative blood loss

    Time frame: At the end of the surgery.

    The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount.

  2. Preoperative and postoperative hemoglobin change

    Time frame: On postoperative day 0 and day 2

    Preoperative and postoperative hemoglobin values will be recorded.

Secondary outcomes

  1. Need for postoperative blood transfusion

    Time frame: Postoperative day 1

    Patients who received postoperative blood transfusions will be recorded.

  2. Operation time

    Time frame: At the end of the operation.

    Operation time will be recorded.

  3. Postoperative thrombosis symptoms

    Time frame: At postoperative first week and 3rd month.

    Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2022
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.