Placenta AccretaPhase 3NCT02329756
Tranexamic Acid in Adherent Placenta (TAP)
A Phase 3 study testing Tranexamic Acid (TXA) and Sodium Chloride 0.9% in people with Placenta Accreta, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The objective of this study is to investigate the effect of tranexamic acid (TXA) administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly Adherent Placenta (MAP; placenta accreta, increta, percreta). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Tranexamic Acid (TXA) and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2018to Dec 2021
- Phase
- Phase 3
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ultrasound and/or MRI diagnosed MAPL pregnancy scheduled to have a cesarean hysterectomy
- The responsible clinician is substantially uncertain as to whether or not to use TXA
- Consent has been given according to approved procedures
Who cannot join
- Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized
- Prior known thromboembolic event during pregnancy
- Known contraindication to TXA (prior adverse reaction)
- Patient unable to give adequate consent due to emergent cesarean hysterectomy
- Bleeding prior to incision
- Prior known thromboembolic event
- Women with a history of any acute venous or arterial thrombosis including retinal artery/retinal vein occlusion, cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism
- History of decreased renal function, renal cortical disease, or significant renal tract disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial
The objective of this study is to investigate the effect of tranexamic acid (TXA) administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly Adherent Placenta (MAP; placenta accreta, increta, percreta).
Read the detailed description
This trial is a randomized, double blind, placebo controlled trial to quantify the effects of the preoperative administration of tranexamic acid on estimated blood loss and blood product utilization in women undergoing cesarean-hysterectomy for suspected MAP. Subgroup analyses will be performed for laboratory results (coagulation studies, electrolytes, complete blood count), urine output, hemodynamic parameters, return to OR for continued bleeding, post-operative complications (thromboembolism, wound separation, infection, fever), and length of hospital stay. Eligible patients will be randomized to receive either TXA or placebo.
Women eligible for inclusion will be identified during their prenatal course or on admission to the hospital prior to surgery. They will be offered participation in the study after appropriate counseling regarding the equipoise regarding TXA and its use in pregnancy, and following a question and answer period they will be consented, and assigned a study number.
A randomization table will be generated by the Texas Children's Hospital Investigational Pharmacy, using balanced blocks of 8, and will maintain control of the randomization to ensure blinding of participants and the clinical investigators. Randomization will occur when an order for study medication will be sent on a paper requisition to the Texas Children's Hospital Investigational Pharmacy, and a randomization number will be assigned to correspond to the study number. Ideally, this order will be sumbitted 24h prior to scheduled surgery, but may be submitted for urgent cases by calling the Texas Children's Clinical Pharmacy, and delivering the paper requisition to the 7th Floor Main Pharmacy.
The Investigational Pharmacy will prepare study medication (Tranexamic acid I.V. or Normal saline as placebo) as determined by the randomization. The medication (whether study medication or placebo) will be packaged in identical syringes. Sealed, opaque envelopes will be available to the PI or an assigned designee to permit unblinding (linking randomization number and study number) only in the event of a clinical emergency involving a study partipant during times at which the Investigational Pharmacy is closed (nights, weekends, holidays).
Once a patient has been randomized, the outcome in hospital will be collected even if the study medication is interrupted or not actually given.
- Conditions
- Placenta Accreta
- Being tested
- Tranexamic Acid (TXA), Sodium Chloride 0.9%
- Keywords
- Tranexamic Acid
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called Cyklokapron
1g Tranexamic Acid (TXA) will be given at the time of delivery. If in 30 minutes, heavy bleeding continues, a 2nd dose will be administered.
Sodium Chloride 0.9%Drug
Also called NaCl
Dose 1: 1 gram - to be administered by intravenous injection at an approximate rate of 1 mL/minute to all randomized women approximately 10 minutes prior to induction of anesthesia
Dose 2: 1 gram - If 30 minutes after beginning the cesarean section there is significant bleeding as defined by the need for the transfusion of 4 or more units of blood products, or if there is a rebleed within the 24 hours after the first dose, a second dose may be given. To be administered by intravenous injection at an approximate rate of 1 mL/minute.
The trial treatment injections should not be mixed with blood for transfusion, or infusion solutions containing penicillin or mannitol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Tranexamic acid (TXA) will be compared with matching placebo (sodium chloride 0.9%). Receives: Drug: Tranexamic Acid (TXA) |
| Control | Placebo comparator | Matching placebo (sodium chloride 0.9%) will be compared with treatment group Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss (EBL)
Our data from the past 65 cases of MAPL performed by our team over the past 3 years shows a 2500 +/- 500ml mean blood loss with these surgeries. Using pooled estimates of the reduction in blood loss published in the literature, a 30% reduction is a reasonable expectation.
Measured: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Blood product requirements
The administration of a fixed dose is more practicable in this study and we have thus selected a fixed dose of 1 gram of TXA 10 minutes prior to induction of anesthesia, followed by a second dose of 1 gram if heavy bleeding is encountered 30 or more minutes after starting the cesarean section which requires the transfusion of 4 or more units of blood products. This is within the dose range which has been shown to inhibit fibrinolysis and provide hemostatic benefit.
Measured: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Hemoglobin level change post surgery
The level of hemoglobin change will be measured after surgery.
Measured: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Secondary outcomes (1)
Thromboembolic events
Data from all thromboembolic events will be documented on CRFs, including but not limited to the amount and severity of events.
Measured: From time patient is given treatment up to 12 weeks post-partum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: More preparation needed prior to collecting data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Anneliese Fox M.D., M.Ed., Baylor College of Medicine
- Investigators
- Michael A Belfort, MD, PhD, Principal investigator, Baylor College of MedicineKarin A Fox, MD,MEd, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329756
- Sponsor's protocol ID
- H-41847
- Other IDs
- H-41847
- Status last verified
- Aug 2018
- First submitted
- 29 Dec 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02329756
- Acronym / sponsor ID
- H-41847
- Conditions
- Placenta Accreta
- Keywords
- Tranexamic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: More preparation needed prior to collecting data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Jan 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 objective of this study is to investigate the effect of tranexamic acid (TXA) administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly Adherent Placenta (MAP; placenta accreta, increta, percreta).
Detailed description
This trial is a randomized, double blind, placebo controlled trial to quantify the effects of the preoperative administration of tranexamic acid on estimated blood loss and blood product utilization in women undergoing cesarean-hysterectomy for suspected MAP. Subgroup analyses will be performed for laboratory results (coagulation studies, electrolytes, complete blood count), urine output, hemodynamic parameters, return to OR for continued bleeding, post-operative complications (thromboembolism, wound separation, infection, fever), and length of hospital stay. Eligible patients will be randomized to receive either TXA or placebo.
Women eligible for inclusion will be identified during their prenatal course or on admission to the hospital prior to surgery. They will be offered participation in the study after appropriate counseling regarding the equipoise regarding TXA and its use in pregnancy, and following a question and answer period they will be consented, and assigned a study number.
A randomization table will be generated by the Texas Children's Hospital Investigational Pharmacy, using balanced blocks of 8, and will maintain control of the randomization to ensure blinding of participants and the clinical investigators. Randomization will occur when an order for study medication will be sent on a paper requisition to the Texas Children's Hospital Investigational Pharmacy, and a randomization number will be assigned to correspond to the study number. Ideally, this order will be sumbitted 24h prior to scheduled surgery, but may be submitted for urgent cases by calling the Texas Children's Clinical Pharmacy, and delivering the paper requisition to the 7th Floor Main Pharmacy.
The Investigational Pharmacy will prepare study medication (Tranexamic acid I.V. or Normal saline as placebo) as determined by the randomization. The medication (whether study medication or placebo) will be packaged in identical syringes. Sealed, opaque envelopes will be available to the PI or an assigned designee to permit unblinding (linking randomization number and study number) only in the event of a clinical emergency involving a study partipant during times at which the Investigational Pharmacy is closed (nights, weekends, holidays).
Once a patient has been randomized, the outcome in hospital will be collected even if the study medication is interrupted or not actually given.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Tranexamic Acid (TXA)Tranexamic acid (TXA) will be compared with matching placebo (sodium chloride 0.9%). |
| Control | Placebo comparator | Drug: Sodium Chloride 0.9%Matching placebo (sodium chloride 0.9%) will be compared with treatment group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ultrasound and/or MRI diagnosed MAPL pregnancy scheduled to have a cesarean hysterectomy
- The responsible clinician is substantially uncertain as to whether or not to use TXA
- Consent has been given according to approved procedures
Key exclusion criteria (8 listed)
- Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized
- Prior known thromboembolic event during pregnancy
- Known contraindication to TXA (prior adverse reaction)
- Patient unable to give adequate consent due to emergent cesarean hysterectomy
- Bleeding prior to incision
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 (TXA)Also: Cyklokapron1g Tranexamic Acid (TXA) will be given at the time of delivery. If in 30 minutes, heavy bleeding continues, a 2nd dose will be administered. | Drug | Treatment |
| Sodium Chloride 0.9%Also: NaClDose 1: 1 gram - to be administered by intravenous injection at an approximate rate of 1 mL/minute to all randomized women approximately 10 minutes prior to induction of anesthesia Dose 2: 1 gram - If 30 minutes after beginning the cesarean section there is significant bleeding as defined by the need for the transfusion of 4 or more units of blood products, or if there is a rebleed within the 24 hours after the first dose, a second dose may be given. To be administered by intravenous injection at an approximate rate of 1 mL/minute. The trial treatment injections should not be mixed with blood for transfusion, or infusion solutions containing penicillin or mannitol. | Drug | Control |
Primary outcome
Estimated blood loss (EBL)
Time frame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Our data from the past 65 cases of MAPL performed by our team over the past 3 years shows a 2500 +/- 500ml mean blood loss with these surgeries. Using pooled estimates of the reduction in blood loss published in the literature, a 30% reduction is a reasonable expectation.
Blood product requirements
Time frame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
The administration of a fixed dose is more practicable in this study and we have thus selected a fixed dose of 1 gram of TXA 10 minutes prior to induction of anesthesia, followed by a second dose of 1 gram if heavy bleeding is encountered 30 or more minutes after starting the cesarean section which requires the transfusion of 4 or more units of blood products. This is within the dose range which has been shown to inhibit fibrinolysis and provide hemostatic benefit.
Hemoglobin level change post surgery
Time frame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
The level of hemoglobin change will be measured after surgery.
1 secondary outcome
Thromboembolic events
Time frame: From time patient is given treatment up to 12 weeks post-partum.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- 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.
Michael A Belfort, MD, PhD principal investigator
Baylor College of Medicine
Karin A Fox, MD,MEd principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid (TXA) and Sodium Chloride 0.9% in people with Placenta Accreta, run by Baylor College of Medicine 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Aug 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Estimated blood loss (EBL) (time frame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first). 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?
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 Aug 2018.