Placenta AccretaPhase 4TAPPASNCT02806024
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
A Phase 4 study testing Tranexamic Acid in people with Placenta Accreta and Postpartum Hemorrhage, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Placenta Accreta, Postpartum Hemorrhage, Cesarean Section
- 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English and Spanish speaking pregnant women
- Any order pregnancy (singleton, twin gestation, etc)
- Suspected accreta based on ultrasound or MRI imaging studies
- All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections
Who cannot join
- Women less than 18 years of age
- Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome
- Women who do not have a good understanding of either English or Spanish will be excluded.
- Women with defective color vision (color-blindness)
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Medical Center
Fresno, California, 93721
About this study
Official title: Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
Read the detailed description
To date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. There has been growing interest in the application of tranexamic acid in obstetrics and gynecology. In multiple international studies, intravenous TXA has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. TXA has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.
- Being tested
- Tranexamic Acid, Placebo Drug
- Medical subject headings
- Placenta Accreta, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Placebo DrugDrug
50 cc Normal Saline IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) | Experimental | Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once. Receives: Drug: Tranexamic Acid |
| Placebo Arm | Placebo comparator | Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant. Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss (EBL)
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).
Measured: 1-3 hours (will be determined at the completion of the surgery).
Secondary outcomes (1)
Blood Transfusion (Number of Units Transfused) Intraoperatively
Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome.
Measured: Pulled from operative note, completed by the time of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Central California Faculty Medical Group
- Responsible party
- Principal investigator, Mallory Kremer, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806024
- Sponsor's protocol ID
- 2016036
- Acronym
- TAPPAS
- Status last verified
- Nov 2019
- First submitted
- 10 Jun 2016
- Last updated
- 3 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
PubMed 26079202Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
PubMed 16738145Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gulmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10.
PubMed 23574458
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
- ClinicalTrials.gov ID
- NCT02806024
- Acronym / sponsor ID
- TAPPAS / 2016036
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Central California Faculty Medical Group
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 3 Dec 2019
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 pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
Detailed description
To date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. There has been growing interest in the application of tranexamic acid in obstetrics and gynecology. In multiple international studies, intravenous TXA has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. TXA has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) | Experimental | Drug: Tranexamic AcidPatients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once. |
| Placebo Arm | Placebo comparator | Drug: Placebo DrugPatients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English and Spanish speaking pregnant women
- Any order pregnancy (singleton, twin gestation, etc)
- Suspected accreta based on ultrasound or MRI imaging studies
- All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections
Key exclusion criteria (5 listed)
- Women less than 18 years of age
- Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome
- Women who do not have a good understanding of either English or Spanish will be excluded.
- Women with defective color vision (color-blindness)
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 | Treatment Arm (Tranexamic Acid, or TXA) |
| Placebo Drug50 cc Normal Saline IV | Drug | Placebo Arm |
Primary outcome
Estimated Blood Loss (EBL)
Time frame: 1-3 hours (will be determined at the completion of the surgery).
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).
1 secondary outcome
Blood Transfusion (Number of Units Transfused) Intraoperatively
Time frame: Pulled from operative note, completed by the time of discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26079202Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
- Background: PubMed 16738145Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
- Background: PubMed 23574458Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gulmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10.
- Individual participant dataSharing planned: No
Related trials for Placenta Accreta
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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 4 study testing Tranexamic Acid in people with Placenta Accreta and Postpartum Hemorrhage, run by University of California, San Francisco 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 4 inclusion and 5 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 3 Dec 2019. 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 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?
Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 1-3 hours (will be determined at the completion of the surgery).). 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 NCT02806024, which also lists 3 linked publications.
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 3 Dec 2019.