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

Leiomyoma, Uterine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517590
• Other study ID #: ATADEK-2022/05-33
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intraoperative Blood Loss
• Leiomyoma
• Leiomyoma, Uterine

Intervention

Drug:
• Tranexamic acid
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.
• Saline
100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul	Sariyer

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Buckley VA, Nesbitt-Hawes EM, Atkinson P, Won HR, Deans R, Burton A, Lyons SD, Abbott JA. Laparoscopic myomectomy: clinical outcomes and comparative evidence. J Minim Invasive Gynecol. 2015 Jan;22(1):11-25. doi: 10.1016/j.jmig.2014.08.007. Epub 2014 Aug 10. — View Citation

Jin C, Hu Y, Chen XC, Zheng FY, Lin F, Zhou K, Chen FD, Gu HZ. Laparoscopic versus open myomectomy--a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009 Jul;145(1):14-21. doi: 10.1016/j.ejogrb.2009.03.009. Epub 2009 Apr 23. — View Citation

Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. — View Citation

LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900. — View Citation

Okolo S. Incidence, aetiology and epidemiology of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008 Aug;22(4):571-88. doi: 10.1016/j.bpobgyn.2008.04.002. Epub 2008 Jun 4. — View Citation

Opoku-Anane J, Vargas MV, Marfori CQ, Moawad G, Maasen MS, Robinson JK. Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2020 Sep;223(3):413.e1-413.e7. doi: 10.1016/j.ajog.2020.02.019. Epub 2020 Mar 28. — View Citation

Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5. — View Citation

Winkler UH. The effect of tranexamic acid on the quality of life of women with heavy menstrual bleeding. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):238-43. doi: 10.1016/s0301-2115(01)00414-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood loss	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.	At the end of the surgery.
Primary	Preoperative and postoperative hemoglobin change	Preoperative and postoperative hemoglobin values will be recorded.	On postoperative day 0 and day 2
Secondary	Need for postoperative blood transfusion	Patients who received postoperative blood transfusions will be recorded.	Postoperative day 1
Secondary	Operation time	Operation time will be recorded.	At the end of the operation.
Secondary	Postoperative thrombosis symptoms	Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.	At postoperative first week and 3rd month.