Clinical trial NCT05517590: Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.
Official title: Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma, Uterine
Intraoperative Blood Loss
Keywords: Leiomyoma
Laparoscopic myomectomy
Tranexamic acid
Blood loss
İntramyometrial desmopressin
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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:

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 \> 1.5 mg/dL)
9. Those allergic to tranexamic acid

Primary outcomes:
measure: Perioperative blood loss
timeFrame: At the end of the surgery.
measure: Preoperative and postoperative hemoglobin change
timeFrame: On postoperative day 0 and day 2
Secondary outcomes:
measure: Need for postoperative blood transfusion
timeFrame: Postoperative day 1
measure: Operation time
timeFrame: At the end of the operation.
measure: Postoperative thrombosis symptoms
timeFrame: At postoperative first week and 3rd month.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Mete Gungor
role: STUDY_DIRECTOR
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