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funding and manpower unavailable, completion within a reasonable timeframe not possible.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treated, low risk PPH | Experimental | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1 gram IV over 10 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one hour after initiation of study infusion |
| Intraoperative Blood Loss | Blood loss will be measured using the following methods:
| 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:
| 6 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control, Low Risk PPH | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline |
| FG001 | Treated, Low Risk PPH | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients scheduled for elective cesarean delivery with low risk for postpartum hemorrhage.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control, Low Risk PPH | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline |
| BG001 | Treated, Low Risk PPH |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Thromboelastography R-time | Posted | Mean | Inter-Quartile Range | minutes | one hour after initiation of study infusion |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control, Low Risk PPH | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michaela K. Farber | Brigham and Women's Hospital | 6177591609 | mfarber@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo; Normal Saline |
| Drug |
0.9% Normal Saline |
|
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
|
| Primary | Intraoperative Blood Loss | Blood loss will be measured using the following methods:
| weight of surgical sponges | Posted | Mean | Standard Error | milliliters | during surgery in the operating room |
|
|
|
| Primary | 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:
| postpartum Obstetrician evaluation at 6 weeks: obstetric bleeding requiring surgical intervention, blood transfusion, or both; thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event | Posted | Number | complications | 6 weeks postpartum |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Treated, Low Risk PPH | Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes | 0 | 13 | 0 | 13 | 0 | 13 |
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |