Vaginal HysterectomyNCT05921071
Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?
A study testing Tranexamic acid in people with Vaginal Hysterectomy, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate. Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Hysterectomy
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jan 2023to 1 Jan 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).
Who cannot join
- allergy to TXA
- familial or personal history of hypercoagulability disorder or thromboembolic events
- impaired renal function or hematuria
- patients receiving antithrombotic therapy
- additional concurrent abdominal/ laparoscopic procedures
- malignancy
- Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon
Ohad Gluck, MD, 97235028329, ohadgluck@gmail.com
About this study
Official title: Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study
This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
Read the detailed description
This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.
- Conditions
- Vaginal Hysterectomy
- Being tested
- Tranexamic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Hexakapron
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery
PlaceboDrug
Also called Normal Selaine 0.9%
patients will receive 10 ml of normal saline 0.9% intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid arm | Active comparator | One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery. Receives: Drug: Tranexamic acid |
| Placebo arm | Placebo comparator | patients will receive 10 ml of normal saline 0.9% intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean objective assessment of blood loss
Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood.
Measured: Immediately after surgery
Secondary outcomes (4)
Mean subjective blood loss (SBL)
SBL will be estimated by the senior surgeon.
Measured: Immediately after surgery
Mean difference in hemoglobin levels before and after surgery
Preoperative and postoperative hemoglobin level difference
Measured: One day after surgery
The number of patients who need blood products transfusion
The need of blood transfusion or other blood products in order to treat excessive blood loss
Measured: 30 days after surgery
The size of pelvic hematoma after surgery
Postoperative pelvic hematoma, diagnosed and measured by ultrasound
Measured: One day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start22 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HysterectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ohad Gluck, Wolfson Medical Center
- Investigators
- Ohad Gluck, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921071
- Sponsor's protocol ID
- WOMC-22-0200
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study
- ClinicalTrials.gov ID
- NCT05921071
- Acronym / sponsor ID
- WOMC-22-0200
- Conditions
- Vaginal Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Jun 2023 (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.
This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
Detailed description
This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid arm | Active comparator | Drug: Tranexamic acidOne gram of tranexamic acid (Hexakapron) is administered intravenously before surgery. |
| Placebo arm | Placebo comparator | Drug: Placebopatients will receive 10 ml of normal saline 0.9% intravenously. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).
Key exclusion criteria (7 listed)
- allergy to TXA
- familial or personal history of hypercoagulability disorder or thromboembolic events
- impaired renal function or hematuria
- patients receiving antithrombotic therapy
- additional concurrent abdominal/ laparoscopic procedures
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: HexakapronOne gram of tranexamic acid (Hexakapron) is administered intravenously before surgery | Drug | Tranexamic acid arm |
| PlaceboAlso: Normal Selaine 0.9%patients will receive 10 ml of normal saline 0.9% intravenously. | Drug | Placebo arm |
Primary outcome
Mean objective assessment of blood loss
Time frame: Immediately after surgery
Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood.
4 secondary outcomes
Mean subjective blood loss (SBL)
Time frame: Immediately after surgery
Mean difference in hemoglobin levels before and after surgery
Time frame: One day after surgery
The number of patients who need blood products transfusion
Time frame: 30 days after surgery
The size of pelvic hematoma after surgery
Time frame: One day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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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.
Ohad Gluck principal investigator
Wolfson Medical Center
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 in people with Vaginal Hysterectomy, run by Wolfson Medical Center at 1 site 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 7 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 23 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ohad Gluck (0528702255, ohadgluck@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean objective assessment of blood loss (time frame: Immediately after 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 23 Apr 2024.