Cesarean Section, Placenta Accreta, Postpartum Hemorrhage, Tranexamic Acid
Conditions
Brief 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. 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.
Interventions
DRUGTranexamic Acid
DRUGPlacebo Drug
50 cc Normal Saline IV
Sponsors
Central California Faculty Medical Group
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss (EBL) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Transfusion (Number of Units Transfused) Intraoperatively | Pulled from operative note, completed by the time of discharge. | Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome. |
Countries
United States
Participant flow
Recruitment details
Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS).
Pre-assignment details
One patient was excluded from the study after consenting to participate, but before delivery. Two consented patients delivered at night, and were unable to be randomized.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) 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.
Tranexamic Acid | 6 |
| Placebo Arm 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.
Placebo Drug: 50 cc Normal Saline IV | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | DVT during antepartum admission | 0 | 1 |
| Overall Study | Night Delivery | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment Arm (Tranexamic Acid, or TXA) | Placebo Arm | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 2.2 | 31.0 years STANDARD_DEVIATION 7.9 | 30.2 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 4 / 6 | 3 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Estimated Blood Loss (EBL)
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy).
Time frame: 1-3 hours (will be determined at the completion of the surgery).
Population: Mean estimated blood loss (EBL) was calculated as below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) | Estimated Blood Loss (EBL) | 3116 cc | Standard Deviation 3947 |
| Placebo Arm | Estimated Blood Loss (EBL) | 9420 cc | Standard Deviation 12474 |
Secondary
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.
Time frame: Pulled from operative note, completed by the time of discharge.
Population: The mean pRBCs units given intraoperatively is presented in the table below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) | Blood Transfusion (Number of Units Transfused) Intraoperatively | 5.2 units | Standard Deviation 8 |
| Placebo Arm | Blood Transfusion (Number of Units Transfused) Intraoperatively | 17.6 units | Standard Deviation 25 |