Trial Outcomes & Findings for Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (NCT NCT02806024)
NCT ID: NCT02806024
Last Updated: 2019-12-03
Results Overview
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
1-3 hours (will be determined at the completion of the surgery).
Results posted on
2019-12-03
Participant Flow
Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS).
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Night Delivery
|
1
|
1
|
|
Overall Study
DVT during antepartum admission
|
0
|
1
|
Baseline Characteristics
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
Baseline characteristics by cohort
| Measure |
Treatment Arm (Tranexamic Acid, or TXA)
n=6 Participants
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
|
Placebo Arm
n=5 Participants
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
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-3 hours (will be determined at the completion of the surgery).Population: Mean estimated blood loss (EBL) was calculated as below.
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).
Outcome measures
| Measure |
Treatment Arm (Tranexamic Acid, or TXA)
n=6 Participants
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
|
Placebo Arm
n=5 Participants
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
|
|---|---|---|
|
Estimated Blood Loss (EBL)
|
3116 cc
Standard Deviation 3947
|
9420 cc
Standard Deviation 12474
|
SECONDARY outcome
Timeframe: Pulled from operative note, completed by the time of discharge.Population: The mean pRBCs units given intraoperatively is presented in the table below.
Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome.
Outcome measures
| Measure |
Treatment Arm (Tranexamic Acid, or TXA)
n=6 Participants
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
|
Placebo Arm
n=5 Participants
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
|
|---|---|---|
|
Blood Transfusion (Number of Units Transfused) Intraoperatively
|
5.2 units
Standard Deviation 8
|
17.6 units
Standard Deviation 25
|
Adverse Events
Treatment Arm (Tranexamic Acid, or TXA)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm (Tranexamic Acid, or TXA)
n=6 participants at risk
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
|
Placebo Arm
n=5 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
DVT / PE
|
0.00%
0/6 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
0.00%
0/5 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
Other adverse events
| Measure |
Treatment Arm (Tranexamic Acid, or TXA)
n=6 participants at risk
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
|
Placebo Arm
n=5 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract injury during surgery (cystotomy or ureter injury)
|
33.3%
2/6 • Number of events 2 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
40.0%
2/5 • Number of events 2 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
|
Surgical and medical procedures
Wound infection
|
16.7%
1/6 • Number of events 1 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
20.0%
1/5 • Number of events 1 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
|
Surgical and medical procedures
IR balloon complication
|
16.7%
1/6 • Number of events 1 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
0.00%
0/5 • Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place