A Phase 2 interventional study of Tranexamic Acid and Placebo; Normal Saline in Postpartum Hemorrhage, sponsored by Brigham and Women's Hospital. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Prevention
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:
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 60 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Drug: Placebo; Normal Saline
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Drug: Tranexamic Acid
1 gram IV over 10 minutes
0.9% Normal Saline
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.
Time frame: 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
Time frame: 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
Time frame: 6 weeks postpartum
| Milestone | Control, Low Risk PPH | Treated, Low Risk PPH |
|---|---|---|
| Started | 7 | 13 |
| Completed | 7 | 13 |
| Not completed | 0 | 0 |
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.
| minutes | Control, Low Risk PPH | Treated, Low Risk PPH |
|---|---|---|
| TEG Value- Thromboelastography R-time, Control and Treated Groups | 5.3 (4.2 to 7.7) | 4.2 (3.4 to 6.0) |
Blood loss will be measured using the following methods: * visual estimate of blood in the suction canister * weight of surgical sponges * postoperative hemoglobin values
| milliliters | Control, Low Risk PPH | Treated, Low Risk PPH |
|---|---|---|
| Intraoperative Blood Loss | 637 ± 151 | 685 ± 155 |
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
| complications | Control, Low Risk PPH | Treated, Low Risk PPH |
|---|---|---|
| Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician. | 0 | 0 |
Collected over All patients enrolled in this study were evaluated in the immediate treatment period through the time of discharge (average duration 4 days) and then records were reviewed from the 6-week postpartum followup for delayed complications.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control, Low Risk PPH | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Treated, Low Risk PPH | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
Patients scheduled for elective cesarean delivery with low risk for postpartum hemorrhage.
| Age, Categorical(Participants) | Control, Low Risk PPH | Treated, Low Risk PPH | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 13 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control, Low Risk PPH | Treated, Low Risk PPH | Total |
|---|---|---|---|
| Mean | 35.2 (30 to 40) | 31.9 (20 to 39) | 32.9 (20 to 40) |
| Sex: Female, Male(Participants) | Control, Low Risk PPH | Treated, Low Risk PPH | Total |
|---|---|---|---|
| Female | 7 | 13 | 20 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control, Low Risk PPH | Treated, Low Risk PPH | Total |
|---|---|---|---|
| United States | 7 | 13 | 20 |
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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