Blood LossNCT04760301
Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss
A study testing local tranexamic acid injection and local normal saline injection to cervix in people with Blood Loss, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation Read more about this study
- Who is it for?
- Ages 20 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- local tranexamic acid injection and local normal saline injection to cervix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 16 Feb 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-90 years old female patients going through vaginal hysterctomy
Who cannot join
- massive bleeding during operation due to major vessles injury
- known coagulopathies
- sensitivity to tranexamic acid
- medical need in tranexamic acid administration during operation due to bleeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Not yet recruiting
Meir Medical Center
Kfar Saba, Israel, 11125
Yair M Daykan, MD, 972-54-2198231, yair.dykan@gmail.com
- Recruiting
Meir medical center
Kfar Saba
Yair Dykan, MD, 09-7472209, yair.dykan@gmail.com
About this study
Official title: Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation
Read the detailed description
This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.
The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.
- Conditions
- Blood Loss
- Being tested
- local tranexamic acid injection, local normal saline injection to cervix
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local tranexamic acid injectionDrug
Also called Hexakapron
local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
local normal saline injection to cervixOther
local normal saline injection to the cervix- 20 ml saline
| Study group | Role | What they receive |
|---|---|---|
| local tranexamic acid injection to cervix | Experimental | 1 gr of Tranexamic acid diluted in 10 ml saline Receives: Drug: local tranexamic acid injection |
| local normal saline injection to cervix | Placebo comparator | 20 ml of saline Receives: Other: local normal saline injection to cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss during operation - measure in ml
At the end of the surgery, surgeon will measure the blood in the suction can
Measured: End of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start16 Feb 2021
- Primary completionJul 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Daykan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760301
- Sponsor's protocol ID
- 0354-19-MMC
- Status last verified
- May 2025
- First submitted
- 16 Feb 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
- ClinicalTrials.gov ID
- NCT04760301
- Acronym / sponsor ID
- 0354-19-MMC
- Conditions
- Blood Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Feb 2021 (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.
Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation
Detailed description
This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.
The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local tranexamic acid injection to cervix | Experimental | Drug: local tranexamic acid injection1 gr of Tranexamic acid diluted in 10 ml saline |
| local normal saline injection to cervix | Placebo comparator | Other: local normal saline injection to cervix20 ml of saline |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20-90 years old female patients going through vaginal hysterctomy
Key exclusion criteria (4 listed)
- massive bleeding during operation due to major vessles injury
- known coagulopathies
- sensitivity to tranexamic acid
- medical need in tranexamic acid administration during operation due to bleeding
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 |
|---|---|---|
| local tranexamic acid injectionAlso: Hexakapronlocal tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline | Drug | local tranexamic acid injection to cervix |
| local normal saline injection to cervixlocal normal saline injection to the cervix- 20 ml saline | Other | local normal saline injection to cervix |
Primary outcome
Blood loss during operation - measure in ml
Time frame: End of surgery
At the end of the surgery, surgeon will measure the blood in the suction can
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local tranexamic acid injection and local normal saline injection to cervix in people with Blood Loss, run by Meir Medical Center at 2 sites in Israel.
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 4 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: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yair Daykan, M.D (0542198231, yair.dykan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss during operation - measure in ml (time frame: End of surgery). 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 6 May 2025.