Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.
Primary Purpose
Leiomyoma, Uterine, Intraoperative Blood Loss
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic acid
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Leiomyoma, Uterine focused on measuring Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin
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:
- 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
Sites / Locations
- Acibadem Maslak HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tranexamic acid and group (Group I)
Saline group (Group II)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Preoperative and postoperative hemoglobin change
Preoperative and postoperative hemoglobin values will be recorded.
Secondary Outcome Measures
Need for postoperative blood transfusion
Patients who received postoperative blood transfusions will be recorded.
Operation time
Operation time will be recorded.
Postoperative thrombosis symptoms
Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.
Full Information
NCT ID
NCT05517590
First Posted
August 23, 2022
Last Updated
September 20, 2023
Sponsor
Acibadem University
1. Study Identification
Unique Protocol Identification Number
NCT05517590
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine, Intraoperative Blood Loss
Keywords
Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid and group (Group I)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline group (Group II)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Group I
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Group II
Intervention Description
100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.
Primary Outcome Measure Information:
Title
Perioperative blood loss
Description
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.
Time Frame
At the end of the surgery.
Title
Preoperative and postoperative hemoglobin change
Description
Preoperative and postoperative hemoglobin values will be recorded.
Time Frame
On postoperative day 0 and day 2
Secondary Outcome Measure Information:
Title
Need for postoperative blood transfusion
Description
Patients who received postoperative blood transfusions will be recorded.
Time Frame
Postoperative day 1
Title
Operation time
Description
Operation time will be recorded.
Time Frame
At the end of the operation.
Title
Postoperative thrombosis symptoms
Description
Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.
Time Frame
At postoperative first week and 3rd month.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Ozbasli, MD
Phone
00905325120114
Email
esraizmit@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ozguc Takmaz, MD
Phone
00905554006591
Email
ozguctakmaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mete Gungor
Organizational Affiliation
Acıbadem Mehmet Ali Aydınlar University
Official's Role
Study Director
Facility Information:
Facility Name
Acibadem Maslak Hospital
City
Istanbul
State/Province
Sariyer
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Ozbasli, MD
Phone
+902123044495
Email
esra.ozbasli@acibadem.com.tr
First Name & Middle Initial & Last Name & Degree
Ozguc Takmaz, MD
Phone
+902123044497
Email
ozgur.takmaz@acibadem.com.tr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol, statistical analysis might be shared when the study is completed upon request.
Citations:
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PubMed Identifier
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Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
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Results Reference
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Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.
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