Leiomyoma, UterineNCT05517590
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.
A study testing Tranexamic acid and Saline in people with Leiomyoma, Uterine and Intraoperative Blood Loss, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma, Uterine, Intraoperative Blood Loss
- What is being tested?
- Tranexamic acid and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.
Who cannot join
- 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
Show all 9Show fewer
- Patients using anticoagulants
- Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL)
- Those allergic to tranexamic acid
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Istanbul, Sariyer, 34457
About this study
Official title: Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial
To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.
Read the 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.
- Conditions
- Leiomyoma, Uterine, Intraoperative Blood Loss
- Being tested
- Tranexamic acid, Saline
- Keywords
- Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin
- Medical subject headings
- Leiomyoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Group I
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.
SalineDrug
Also called Group II
100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid and group (Group I) | Active comparator | In Group I, 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. Receives: Drug: Tranexamic acid |
| Saline group (Group II) | Placebo comparator | Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the surgery.
Preoperative and postoperative hemoglobin change
Preoperative and postoperative hemoglobin values will be recorded.
Measured: On postoperative day 0 and day 2
Secondary outcomes (3)
Need for postoperative blood transfusion
Patients who received postoperative blood transfusions will be recorded.
Measured: Postoperative day 1
Operation time
Operation time will be recorded.
Measured: At the end of the operation.
Postoperative thrombosis symptoms
Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.
Measured: At postoperative first week and 3rd month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Leiomyoma, UterineStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ozbasli, Acibadem University
- Investigators
- Mete Gungor, Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517590
- Sponsor's protocol ID
- ATADEK-2022/05-33
- Status last verified
- May 2024
- First submitted
- 23 Aug 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, statistical analysis might be shared when the study is completed upon request.
Publications
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.
PubMed 18534913Buckley 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.
PubMed 25117840Jin 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.
PubMed 19398260LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900.
PubMed 8233261Kongnyuy 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.
PubMed 25125317Opoku-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.
PubMed 32229194Srivastava 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.
PubMed 30056355Winkler 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.
PubMed 11788179
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05517590
- Acronym / sponsor ID
- ATADEK-2022/05-33
- Conditions
- Leiomyoma, Uterine, Intraoperative Blood Loss
- Keywords
- Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid and group (Group I) | Active comparator | Drug: Tranexamic acidIn Group I, 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 group (Group II) | Placebo comparator | Drug: SalineGroup II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: Group I1 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 | Tranexamic acid and group (Group I) |
| SalineAlso: Group II100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time. | Drug | Saline group (Group II) |
Primary outcome
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.
3 secondary outcomes
Need for postoperative blood transfusion
Time frame: Postoperative day 1
Operation time
Time frame: At the end of the operation.
Postoperative thrombosis symptoms
Time frame: At postoperative first week and 3rd month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 8233261LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Individual participant dataSharing planned: No. Study protocol, statistical analysis might be shared when the study is completed upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mete Gungor study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and Saline in people with Leiomyoma, Uterine and Intraoperative Blood Loss, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (time frame: At the end of the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517590, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.