Surgical Blood LossPhase 3NCT03122782
Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
A Phase 3 study testing Topical application Tranexamic acid in people with Surgical Blood Loss and Fibroid, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Blood Loss, Fibroid
- What is being tested?
- Topical application Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to Jan 2018
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient with Cardiopulmonary, Hepatic , and renal diseases
- Patient with metabolic disorders including diabetes
- Patients with uterine septum or structural abnormality
Trial locations and contacts
No sites are listed yet.
About this study
Study Design:
Randomized Controlled Clinical Trial.
Read more
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.
- Conditions
- Surgical Blood Loss, Fibroid
- Being tested
- Topical application Tranexamic acid, Placebo (Normal saline)
- Medical subject headings
- Blood Loss, Surgical, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application Tranexamic acidDrug
Also called KAPRON (AMOUN Pharmaceutical co.)
Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy
Placebo (Normal saline)Drug
5ml of normal saline will be added to every 500 ml of distension media
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid (TXA) Group | Active comparator | 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. Receives: Drug: Topical application Tranexamic acid |
| Normal Saline (control group) | Placebo comparator | Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy. Receives: Drug: Placebo (Normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Aug 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajer Soliman, Ain Shams University
- Investigators
- Ahmed Khairyy Makled, MD, Study chair, Ain Shams UniversityAmgad Said Abu-Gamra, MD, Study chair, Ain Shams UniversityRadwa Ali Rasheedy, MD, Study director, Ain Shams UniversityHajer Giuma Soliman, M.B.B.CH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122782
- Sponsor's protocol ID
- ASU-2016-2
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
- ClinicalTrials.gov ID
- NCT03122782
- Acronym / sponsor ID
- ASU-2016-2
- Conditions
- Surgical Blood Loss, Fibroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Apr 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) Group | Active comparator | Drug: Topical application Tranexamic acidSubjects 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. |
| Normal Saline (control group) | Placebo comparator | Drug: Placebo (Normal saline)Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Topical application Tranexamic acidAlso: KAPRON (AMOUN Pharmaceutical co.)Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy | Drug | Tranexamic acid (TXA) Group |
| Placebo (Normal saline)5ml of normal saline will be added to every 500 ml of distension media | Drug | Normal Saline (control group) |
Primary outcome
Estimated blood loss by comparing changes in hemoglobin level
Time frame: 24 Hours
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
Time frame: 24 hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
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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.
Ahmed Khairyy Makled, MD study chair
Ain Shams University
Amgad Said Abu-Gamra, MD study chair
Ain Shams University
Radwa Ali Rasheedy, MD study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical application Tranexamic acid in people with Surgical Blood Loss and Fibroid, run by Ain Shams University.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa Ali Rasheedy, MD (01283492979, Radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss by comparing changes in hemoglobin level (time frame: 24 Hours). 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?
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 29 Jun 2017.