Uterine SurgeryPhase 4NCT06290596
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy
A Phase 4 study testing Vasopressin, Tranexamic acid and Saline in people with Uterine Surgery, run by Al-Azhar University.
Trial summary
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Uterine Surgery
- What is being tested?
- Vasopressin, Tranexamic acid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Oct 2024
- Phase
- Phase 4
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.
Who cannot join
- history of coagulation or bleeding disorders or
- if they were under antithrombotic treatment.
- associated malignancy, renal impairment or allergy to TA.
About this study
Official title: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy: A Randomized Clinical Study
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
Read the detailed description
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group
- Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
- Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
- Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
- Conditions
- Uterine Surgery
- Being tested
- Vasopressin, Tranexamic acid, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Hemostatic drug.
Tranexamic acidDrug
Hemostatic drug.
SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin group | Experimental | patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally) Receives: Drug: Vasopressin |
| Tranexamic acid group | Experimental | patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally). Receives: Drug: Tranexamic acid |
| Control group | Placebo comparator | patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally). Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Amount of blood loss in mL
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 posted4 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SurgeryStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warda Demerdash Khalifa Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290596
- Sponsor's protocol ID
- MSR/AZAST/AIP029/21/222/8/2023
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06290596
- Acronym / sponsor ID
- MSR/AZAST/AIP029/21/222/8/2023
- Conditions
- Uterine Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 4 Mar 2024 (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.
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
Detailed description
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group
- Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
- Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
- Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vasopressin group | Experimental | Drug: Vasopressinpatients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally) |
| Tranexamic acid group | Experimental | Drug: Tranexamic acidpatients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally). |
| Control group | Placebo comparator | Other: Salinepatients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.
Key exclusion criteria (3 listed)
- history of coagulation or bleeding disorders or
- if they were under antithrombotic treatment.
- associated malignancy, renal impairment or allergy to TA.
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 |
|---|---|---|
| VasopressinHemostatic drug. | Drug | Vasopressin group |
| Tranexamic acidHemostatic drug. | Drug | Tranexamic acid group |
| SalinePlacebo | Other | Control group |
Primary outcome
blood loss
Time frame: 24 hours
Amount of blood loss in mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressin, Tranexamic acid and Saline in people with Uterine Surgery, run by Al-Azhar 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 1 inclusion and 3 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 6 Mar 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: 24 hours). 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 Mar 2024.