Hemorrhage/Blood Loss During MyomectomiesPhase 1TANCT02620748
Use of Intravenous Tranexamic Acid During Myomectomy
A Phase 1 study testing Tranexamic Acid and Saline Solution in people with Hemorrhage/Blood Loss During Myomectomies and Fibroids, run by George Washington University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage/Blood Loss During Myomectomies, Fibroids
- What is being tested?
- Tranexamic Acid and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 22 Feb 2018
- Phase
- Phase 1
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women undergoing laparoscopic, robotic or abdominal myomectomy
- fibroid burden meeting the following criteria based on ultrasound imaging: Fibroids greater than or equal to 10 cm Intramural or Broad Ligament Fibroid greater than or equal to 6 cm Number of fibroids greater than or equal to 5 cm
Who cannot join
- Medical history of the following: thromboembolic disease, ischemic heart disease, malignancy, hematuria, liver disease, chronic kidney disease or subarachnoid hemorrhage
- pregnant women
- women who are nursing
- women with active thrombotic or thromboembolic disease
- women with history of intrinsic risk of thrombosis or thromboembolism
- hypersensitivity to Tranexamic Acid
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- Concurrent use of:
- combination of hormonal contraception
- factor IX complex concentrates
- Anti-inhibitor coagulant concentrates
- all-trans retinoic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial
The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.
Read the detailed description
Worldwide about 25% of women will develop uterine leiomyomas. Most myomas are asymptomatic however 20 to 25% of women with myomas develop symptoms, such as heavy menstrual bleeding, requiring treatment. For women failing medical management and desiring to preserve fertility and/or their uterus, surgical removal of fibroids (myomectomy) is the major option. Myomectomy is associated with both short and long-term complications, most significantly, hemorrhage and need for conversion to hysterectomy in 2% of cases, need for a blood transfusion in up to 20% of cases, prolonged postoperative stay, and can be potentially life-threatening. As such, various treatments have been suggested to decrease blood loss during myomectomy including pharmacologic manipulation of the coagulation cascade using agents such as tranexamic acid (TA). Despite the many described methods to reduce intraoperative bleeding, massive hemorrhage during myomectomy remains a significant challenge to gynecologic surgeons.
TA is a synthetic lysine derivative with antifibrinolytic activity that helps prevent clot break down. It is currently clinically used widely to stop heavy menstrual bleeding and many of the investigators' myomectomy patients are taking oral TA around the time of surgery. Systematic reviews of randomized control trials (RCTs) including over 25,000 patients of tranexamic acid in elective surgery showed that it reduced the risk of a blood transfusion by 34% (relative risk (RR) 0.61, 95% confidence interval (CI) 0.53 to 0.70) without an increased risk in venous thrombus embolus (VTE) or other adverse perioperative outcomes (Henry, 2011). Only one RCT has studied the use of TA during gynecologic surgery. This study was a randomized double blind placebo controlled trial of intravenous TA 10 mg/kg (maximum 1g) versus placebo during myomectomy procedures. Although there was a 63 ml decrease in postoperative blood loss (p<0.01), no significant difference was found between the two groups in terms of perioperative blood loss, change in hemoglobin, or rate of allogeneic blood transfusions. Further studies are needed with different dosing administration to confirm the true role of TA in the reduction of blood loss during myomectomy.
If a difference is seen, the results of future publications would directly impact clinical care locally and abroad, as few methods currently exist to prevent hemorrhage during myomectomy procedures.
- Being tested
- Tranexamic Acid, Saline Solution
- Medical subject headings
- Hemorrhage, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Saline SolutionOther
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | This arm will receive an injection of Tranexamic Acid Receives: Drug: Tranexamic Acid |
| Saline | Placebo comparator | This arm will receive an injection of Saline Solution Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
the volume of blood loss will be measured at end of surgery.
Measured: At time of Surgery
Secondary outcomes (2)
change in pre-operative and immediately post-operative hemoglobin
Measured: At time of Surgery
frequency of blood transfusions
Measured: At time of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startMar 2015
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage/Blood Loss During MyomectomiesStudies of the same condition, open and under way.
- More trials run by George Washington 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620748
- Sponsor's protocol ID
- 091454
- Acronym
- TA
- Status last verified
- Jan 2019
- First submitted
- 1 Dec 2015
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02620748
- Acronym / sponsor ID
- TA / 091454
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.
Detailed description
Worldwide about 25% of women will develop uterine leiomyomas. Most myomas are asymptomatic however 20 to 25% of women with myomas develop symptoms, such as heavy menstrual bleeding, requiring treatment. For women failing medical management and desiring to preserve fertility and/or their uterus, surgical removal of fibroids (myomectomy) is the major option. Myomectomy is associated with both short and long-term complications, most significantly, hemorrhage and need for conversion to hysterectomy in 2% of cases, need for a blood transfusion in up to 20% of cases, prolonged postoperative stay, and can be potentially life-threatening. As such, various treatments have been suggested to decrease blood loss during myomectomy including pharmacologic manipulation of the coagulation cascade using agents such as tranexamic acid (TA). Despite the many described methods to reduce intraoperative bleeding, massive hemorrhage during myomectomy remains a significant challenge to gynecologic surgeons.
TA is a synthetic lysine derivative with antifibrinolytic activity that helps prevent clot break down. It is currently clinically used widely to stop heavy menstrual bleeding and many of the investigators' myomectomy patients are taking oral TA around the time of surgery. Systematic reviews of randomized control trials (RCTs) including over 25,000 patients of tranexamic acid in elective surgery showed that it reduced the risk of a blood transfusion by 34% (relative risk (RR) 0.61, 95% confidence interval (CI) 0.53 to 0.70) without an increased risk in venous thrombus embolus (VTE) or other adverse perioperative outcomes (Henry, 2011). Only one RCT has studied the use of TA during gynecologic surgery. This study was a randomized double blind placebo controlled trial of intravenous TA 10 mg/kg (maximum 1g) versus placebo during myomectomy procedures. Although there was a 63 ml decrease in postoperative blood loss (p<0.01), no significant difference was found between the two groups in terms of perioperative blood loss, change in hemoglobin, or rate of allogeneic blood transfusions. Further studies are needed with different dosing administration to confirm the true role of TA in the reduction of blood loss during myomectomy.
If a difference is seen, the results of future publications would directly impact clinical care locally and abroad, as few methods currently exist to prevent hemorrhage during myomectomy procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic AcidThis arm will receive an injection of Tranexamic Acid |
| Saline | Placebo comparator | Other: Saline SolutionThis arm will receive an injection of Saline Solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women undergoing laparoscopic, robotic or abdominal myomectomy
- fibroid burden meeting the following criteria based on ultrasound imaging: Fibroids greater than or equal to 10 cm Intramural or Broad Ligament Fibroid greater than or equal to 6 cm Number of fibroids greater than or equal to 5 cm
Key exclusion criteria (11 listed)
- Medical history of the following: thromboembolic disease, ischemic heart disease, malignancy, hematuria, liver disease, chronic kidney disease or subarachnoid hemorrhage
- pregnant women
- women who are nursing
- women with active thrombotic or thromboembolic disease
- women with history of intrinsic risk of thrombosis or thromboembolism
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 Acid | Drug | Tranexamic Acid |
| Saline Solution | Other | Saline |
Primary outcome
Blood Loss
Time frame: At time of Surgery
the volume of blood loss will be measured at end of surgery.
2 secondary outcomes
change in pre-operative and immediately post-operative hemoglobin
Time frame: At time of Surgery
frequency of blood transfusions
Time frame: At time of Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic Acid and Saline Solution in people with Hemorrhage/Blood Loss During Myomectomies and Fibroids, run by George Washington University at 1 site in United States.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 13 Oct 2022. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: At time 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 13 Oct 2022.