To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During MyomectomyPhase 2AEFUTHANCT04560465
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
A Phase 2 study testing Tranexamic acid in people with To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy, run by Alex Ekwueme Federal University Teaching Hospital at 1 site in Nigeria.
Trial summary
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution. 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
- To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
- 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
- 59 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2018to 1 Jun 2019
- Phase
- Phase 2
- 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
- non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid
Who cannot join
- past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.
Read the detailed description
A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.
- Being tested
- Tranexamic acid
- Keywords
- Tranexamic acid, Myomectomy, Blood loss, Gravimetric
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control
| Study group | Role | What they receive |
|---|---|---|
| group A: Cases that had tranexamic acid infusion | Experimental | Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour Receives: Drug: Tranexamic acid |
| Group B: Control | Placebo comparator | control were given perioperative placebo at the rate of 100mls per hour Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average duration of surgery in each group
Average duration of Surgeries were calculated for each group
Measured: one year
Mean intraoperative Blood loss
The mean intraoperative blood loss was calculated for both groups
Measured: one year
Postoperative Haemoglobin concentration
Average Postoperative Haemoglobin concentration of both groups were determined
Measured: one year
Secondary outcomes (1)
Blood Transfusion
Risk of Blood Transfusion of both groups were determined
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jun 2018
- Primary completion31 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During MyomectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups comprising of cases and control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alex Ekwueme Federal University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olaleye Ayodele Adegbite, Alex Ekwueme Federal University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560465
- Sponsor's protocol ID
- AEFUTHA
- Acronym
- AEFUTHA
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olaleye AA, Adebayo JA, Eze JN, Ajah LO, Anikwe CC, Egede JO, Ebere CI. Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial. Int J Reprod Med. 2024 Jan 18;2024:2794052. doi: 10.1155/2024/2794052. eCollection 2024.
PubMed 38283394
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki
- ClinicalTrials.gov ID
- NCT04560465
- Acronym / sponsor ID
- AEFUTHA / AEFUTHA
- Keywords
- Tranexamic acid, Myomectomy, Blood loss, Gravimetric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Alex Ekwueme Federal University Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 23 Sep 2020 (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 determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.
Detailed description
A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- two groups comprising of cases and control
| Arm | Type | Receives |
|---|---|---|
| group A: Cases that had tranexamic acid infusion | Experimental | Drug: Tranexamic acidGroup A had perioperative tranexamic acid infusion at the rate of 100mls per hour |
| Group B: Control | Placebo comparator | Drug: Tranexamic acidcontrol were given perioperative placebo at the rate of 100mls per hour |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid
Key exclusion criteria (1 listed)
- past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease
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 acidintravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control | Drug | Group B: Control, group A: Cases that had tranexamic acid infusion |
Primary outcome
Average duration of surgery in each group
Time frame: one year
Average duration of Surgeries were calculated for each group
Mean intraoperative Blood loss
Time frame: one year
The mean intraoperative blood loss was calculated for both groups
Postoperative Haemoglobin concentration
Time frame: one year
Average Postoperative Haemoglobin concentration of both groups were determined
1 secondary outcome
Blood Transfusion
Time frame: One year
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 23 Sep 2020.
- Derived from this study: PubMed 38283394Olaleye AA, Adebayo JA, Eze JN, Ajah LO, Anikwe CC, Egede JO, Ebere CI. Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial. Int J Reprod Med. 2024 Jan 18;2024:2794052. doi: 10.1155/2024/2794052. eCollection 2024.
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 2 study testing Tranexamic acid in people with To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy, run by Alex Ekwueme Federal University Teaching Hospital at 1 site in Nigeria.
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 1 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 23 Sep 2020. 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 Nigeria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Average duration of surgery in each group (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560465, which also lists 1 linked publication.
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 Sep 2020.