Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Primary Purpose
Surgical Blood Loss, Fibroid
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topical application Tranexamic acid
Placebo (Normal saline)
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Blood Loss
Eligibility Criteria
Inclusion Criteria:
- Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
- Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH).
- The submucous myoma are less than 4 cm in diameter
Exclusion Criteria:
- Pregnancy
- Active Pelvic Infection
- Present or History of Cervical or Uterine Caner
- Bleeding Diathesis or patient on anticoagulant
- Contraindication and /or allergy to medication specified in the treatment protocol
- History of ischemic heart disease
- Patient with Cardiopulmonary, Hepatic , and renal diseases
- Patient with metabolic disorders including diabetes
- Patients with uterine septum or structural abnormality
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tranexamic acid (TXA) Group
Normal Saline (control group)
Arm Description
Subjects in the Tranexamic acd (TXA) group will receive intrauterine instillation of 500 mg (100mg/ml) Tranexamic acid per 500 ml normal salin (distention medium) during Hysteroscopic Myomectomy.
Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy.
Outcomes
Primary Outcome Measures
Estimated blood loss by comparing changes in hemoglobin level
Estimated blood loss by comparing changes in hemoglobin level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in Tranexamic acid group comparing to the control group
Estimated blood loss by comparing changes in hematocrit level
Estimated blood loss by comparing changes in hematocrit level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in the Tranexamic acid group comparing to the control group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03122782
Brief Title
Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Official Title
Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Study Design:
Randomized Controlled Clinical Trial.
Study Population:
The study population will be a consecutive series of participants attending the Early Cancer Detection Unit (ECDU) at Ain Shams University Maternity Hospital.
80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be randomized into two groups:
Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the distention medium
Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in the distention medium).
Randomization will be performed using a Computer-generated randomization system.
The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will only be opened after recruitment.
Patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study.
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium.
Therefore, this study will be a randomized double blind prospective clinical
Methodology:
Informed written consent obtained from the participant.
History
Personal history
Menstrual history
Detailed obstetric history
Surgical intervention especially uterine surgeries and any post-operative complication
History of drug intake, especially hormonal treatment or anticoagulant therapy.
Routine preoperative investigations in addition to a serum pregnancy test if pregnancy is suspected.
Physical examination including general, abdominal and pelvic examination.
Hysteroscopy will be performed in the early proliferative phase using normal saline as a distention medium.
Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the injected media.
In intervention group 500 mg of Kapron for every 500 ml of distending media will be added.
In the control group, placebo .i.e. ,normal saline in the same form will be injected inside every 500 ml of the distention medium.
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, our study will be a randomized double blind prospective clinical trial.
Intraoperative bleeding and quality of view will be observed.
A blood sample will be taken from each participant in both groups after 24 hours from the end of the operation for both hemoglobin and hematocrit levels.
Types of outcome measures:
Primary outcome measures:
Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control group.
Secondary outcome measures:
The quality of view, duration of surgery, the volume of injected media, intraoperative complications and the success of the completion of the operation will be secondary outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Blood Loss, Fibroid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid (TXA) Group
Arm Type
Active Comparator
Arm Description
Subjects in the Tranexamic acd (TXA) group will receive intrauterine instillation of 500 mg (100mg/ml) Tranexamic acid per 500 ml normal salin (distention medium) during Hysteroscopic Myomectomy.
Arm Title
Normal Saline (control group)
Arm Type
Placebo Comparator
Arm Description
Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy.
Intervention Type
Drug
Intervention Name(s)
Topical application Tranexamic acid
Other Intervention Name(s)
KAPRON (AMOUN Pharmaceutical co.)
Intervention Description
Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy
Intervention Type
Drug
Intervention Name(s)
Placebo (Normal saline)
Intervention Description
5ml of normal saline will be added to every 500 ml of distension media
Primary Outcome Measure Information:
Title
Estimated blood loss by comparing changes in hemoglobin level
Description
Estimated blood loss by comparing changes in hemoglobin level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in Tranexamic acid group comparing to the control group
Time Frame
24 Hours
Title
Estimated blood loss by comparing changes in hematocrit level
Description
Estimated blood loss by comparing changes in hematocrit level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in the Tranexamic acid group comparing to the control group
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH).
The submucous myoma are less than 4 cm in diameter
Exclusion Criteria:
Pregnancy
Active Pelvic Infection
Present or History of Cervical or Uterine Caner
Bleeding Diathesis or patient on anticoagulant
Contraindication and /or allergy to medication specified in the treatment protocol
History of ischemic heart disease
Patient with Cardiopulmonary, Hepatic , and renal diseases
Patient with metabolic disorders including diabetes
Patients with uterine septum or structural abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa Ali Rasheedy, MD
Phone
01283492979
Email
Radwaebed@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Khairyy Makled, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amgad Said Abu-Gamra, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Radwa Ali Rasheedy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hajer Giuma Soliman, M.B.B.CH
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
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