Current partner codePEPTIDESDE
NCT05517590·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

102

Locations

1

Results

Not posted

Publications

8

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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.

DRUG

Saline

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

Timeline

From registration to results.

  1. First posted

    Aug 26, 2022

  2. Study start

    Sep 1, 2022

  3. Primary completion

    Apr 30, 2024

  4. Study completion

    Apr 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    May 24, 2024

Outcomes

What the study measures.

Primary outcomes

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.

Preoperative and postoperative hemoglobin change

Time frame · On postoperative day 0 and day 2

Preoperative and postoperative hemoglobin values will be recorded.

Secondary outcomes

Need for postoperative blood transfusion

Time frame · Postoperative day 1

Patients who received postoperative blood transfusions will be recorded.

Operation time

Time frame · At the end of the operation.

Operation time will be recorded.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Publications

Results and literature.

PMID 18534913Okolo 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.PMID 25117840Buckley 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.PMID 19398260Jin 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.PMID 8233261LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900.PMID 25125317Kongnyuy 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.PMID 32229194Opoku-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.PMID 30056355Srivastava 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.PMID 11788179Winkler 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.

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