Postpartum HemorrhagePhase 2TA TEGNCT02026297
Tranexamic Acid and Thromboelastography During Cesarean Delivery
A Phase 2 study testing Tranexamic Acid in people with Postpartum Hemorrhage, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 21 Feb 2020
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I or II
- aged 18-50 years
- singleton vertex pregnancy
- scheduled elective cesarean delivery (with or without prior labor) with a planned pfannenstiel incision
Who cannot join
- allergy to tranexamic acid
- history of inherited or acquired thrombophilia
- history of deep vein thrombosis or pulmonary embolism, or use of anticoagulant medication.
- preeclampsia, hemolysis, elevated liver enzymes, low platelet syndrome
- seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Influence of Prophylactic Tranexamic Acid on Thromboelastography During Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean delivery, and 2 hours postpartum.
Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing interest in multimodal approaches to blood conservation during cesarean delivery. Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not been elucidated.
Read more
This study will be conducted as a randomized, double-blind, controlled trial with two study arms: control (60 patients); and treatment (60 patients).
Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured throughout surgery as per standard of care. Patients will all receive IV lactated Ringers' (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general anesthesia conversion, general anesthesia planned), indications and medication doses used will be noted for analysis.
Immediately following induction of anesthesia and prior to skin incision, infusion of study solution will be initiated.
Study solutions will consist of:
- Control group: 100 mL 0.9% normal saline (NS).
- Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured throughout the study. All routine care lab values will be noted. At minimum, one lab panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen, platelet count, aPTT, PT, and TEG).
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid, Placebo; Normal Saline
- Keywords
- postpartum hemorrhage, estimated blood loss, coagulation, thromboelastography, tranexamic acid
- Medical subject headings
- Postpartum Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
1 gram IV over 10 minutes
Placebo; Normal SalineDrug
0.9% Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Control, low risk PPH | Placebo comparator | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Receives: Drug: Placebo; Normal Saline |
| Treated, low risk PPH | Experimental | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEG Value- Thromboelastography R-time, Control and Treated Groups
Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.
Measured: one hour after initiation of study infusion
Intraoperative Blood Loss
Blood loss will be measured using the following methods:
- visual estimate of blood in the suction canister
- weight of surgical sponges
- postoperative hemoglobin values
Measured: during surgery in the operating room
Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician.
The electronic patient record from each patients' 6-week postpartum visit will be reviewed for the following:
- delayed bleeding complications, defined as obstetric bleeding requiring surgical intervention, blood transfusion, or both.
- thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completion21 Feb 2020
Why it stopped: funding and manpower unavailable, completion within a reasonable timeframe not possible.
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.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026297
- Sponsor's protocol ID
- 2013P002452
- Acronym
- TA TEG
- Status last verified
- Oct 2020
- First submitted
- 22 Dec 2013
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prophylactic Tranexamic Acid on Thromboelastography During Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02026297
- Acronym / sponsor ID
- TA TEG / 2013P002452
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, estimated blood loss, coagulation, thromboelastography, tranexamic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding and manpower unavailable, completion within a reasonable timeframe not possible.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean delivery, and 2 hours postpartum.
Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing interest in multimodal approaches to blood conservation during cesarean delivery. Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not been elucidated.
This study will be conducted as a randomized, double-blind, controlled trial with two study arms: control (60 patients); and treatment (60 patients).
Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured throughout surgery as per standard of care. Patients will all receive IV lactated Ringers' (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general anesthesia conversion, general anesthesia planned), indications and medication doses used will be noted for analysis.
Immediately following induction of anesthesia and prior to skin incision, infusion of study solution will be initiated.
Study solutions will consist of:
- Control group: 100 mL 0.9% normal saline (NS).
- Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured throughout the study. All routine care lab values will be noted. At minimum, one lab panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen, platelet count, aPTT, PT, and TEG).
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 |
|---|---|---|
| Control, low risk PPH | Placebo comparator | Drug: Placebo; Normal SalinePatients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. |
| Treated, low risk PPH | Experimental | Drug: Tranexamic AcidPatients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) class I or II
- aged 18-50 years
- singleton vertex pregnancy
- scheduled elective cesarean delivery (with or without prior labor) with a planned pfannenstiel incision
Key exclusion criteria (5 listed)
- allergy to tranexamic acid
- history of inherited or acquired thrombophilia
- history of deep vein thrombosis or pulmonary embolism, or use of anticoagulant medication.
- preeclampsia, hemolysis, elevated liver enzymes, low platelet syndrome
- seizure disorder
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 Acid1 gram IV over 10 minutes | Drug | Treated, low risk PPH |
| Placebo; Normal Saline0.9% Normal Saline | Drug | Control, low risk PPH |
Primary outcome
TEG Value- Thromboelastography R-time, Control and Treated Groups
Time frame: one hour after initiation of study infusion
Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.
Intraoperative Blood Loss
Time frame: during surgery in the operating room
Blood loss will be measured using the following methods: * visual estimate of blood in the suction canister * weight of surgical sponges * postoperative hemoglobin values
Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician.
Time frame: 6 weeks postpartum
The electronic patient record from each patients' 6-week postpartum visit will be reviewed for the following: * delayed bleeding complications, defined as obstetric bleeding requiring surgical intervention, blood transfusion, or both. * thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postpartum Hemorrhage
RecruitingObservational study
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Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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Hemoglobin Testing in Pregnant Patients
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RecruitingPhase 4
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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 2 study testing Tranexamic Acid in people with Postpartum Hemorrhage, run by Brigham and Women's Hospital 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: stopped early, as of the sponsor's last update on 27 Oct 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 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 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?
Yes. Results are posted in the registry (first posted 27 Oct 2020). 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?
TEG Value- Thromboelastography R-time, Control and Treated Groups (time frame: one hour after initiation of study infusion). 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 27 Oct 2020.