Trial Outcomes & Findings for Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery (NCT NCT03856164)
NCT ID: NCT03856164
Last Updated: 2021-01-19
Results Overview
Total blood volume loss will be calculated in milliliters.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
110 participants
Primary outcome timeframe
24 hours postpartum.
Results posted on
2021-01-19
Participant Flow
Participants were recruited based on admission for delivery at an academic center between June 2019 and January 2020. The first participant was enrolled on June 17, 2019, and the last participant was enrolled on January 10, 2020.
Of the 110 enrolled participants, all met inclusion criteria and were randomized.
Participant milestones
| Measure |
Tranexamic Acid
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=55 Participants
Tranexamic Acid for intravenous administration.
Tranexamic Acid: Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Normal saline for intravenous administration.
Placebo: 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 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
Black, non-Hispanic
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Parity
Parity = 1
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Parity
Parity = 2
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Parity
Parity = 3
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Parity
Parity = 4
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Parity
Parity = 5
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
< 25
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
25 - < 30
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
30 - < 35
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
35 - < 40
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
> =40
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours postpartum.Total blood volume loss will be calculated in milliliters.
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Blood Volume Loss
|
2274 milliliters
Standard Deviation 469
|
2407 milliliters
Standard Deviation 388
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Measured from blood sample collection.
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
D-Dimer (µg/mL)
Before Surgery
|
2.9 µg/mL
Standard Deviation 1.5
|
4.0 µg/mL
Standard Deviation 5.3
|
|
D-Dimer (µg/mL)
After Delivery
|
2.4 µg/mL
Standard Deviation 1.3
|
3.8 µg/mL
Standard Deviation 4.7
|
|
D-Dimer (µg/mL)
P.O.D. 1
|
2.1 µg/mL
Standard Deviation 1.2
|
4.3 µg/mL
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Measured from blood sample collection.
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Fibrinogen (mg/dL)
Before Surgery
|
563.5 mg/dL
Standard Deviation 83.9
|
550.7 mg/dL
Standard Deviation 68.2
|
|
Fibrinogen (mg/dL)
After Delivery
|
499.6 mg/dL
Standard Deviation 77
|
484.9 mg/dL
Standard Deviation 82.5
|
|
Fibrinogen (mg/dL)
P.O.D. 1
|
527.4 mg/dL
Standard Deviation 69.8
|
525.4 mg/dL
Standard Deviation 86.1
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Measured from blood sample collection.
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Tissue Plasminogen Activator Antigen (ng/mL)
Before Surgery
|
8.1 ng/mL
Standard Deviation 3.6
|
8.2 ng/mL
Standard Deviation 2.7
|
|
Tissue Plasminogen Activator Antigen (ng/mL)
After Delivery
|
9.0 ng/mL
Standard Deviation 3.7
|
9.6 ng/mL
Standard Deviation 2.9
|
|
Tissue Plasminogen Activator Antigen (ng/mL)
P.O.D. 1
|
7.5 ng/mL
Standard Deviation 3.7
|
7.4 ng/mL
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Measured from blood sample collection.
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Plasminogen Activator Inhibitor-Type-1 (Units/mL)
Before Surgery
|
81.8 IU/mL
Standard Deviation 34.7
|
61.7 IU/mL
Standard Deviation 33.8
|
|
Plasminogen Activator Inhibitor-Type-1 (Units/mL)
After Delivery
|
67.0 IU/mL
Standard Deviation 32.3
|
63.3 IU/mL
Standard Deviation 31.9
|
|
Plasminogen Activator Inhibitor-Type-1 (Units/mL)
P.O.D. 1
|
20.7 IU/mL
Standard Deviation 26.7
|
22.1 IU/mL
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
Before Surgery INTEM Clotting Time
|
149.7 seconds
Standard Deviation 14.4
|
150.5 seconds
Standard Deviation 14.2
|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
After Delivery INTEM Clotting Time
|
137.4 seconds
Standard Deviation 18.3
|
140.7 seconds
Standard Deviation 29.9
|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
P.O.D. 1 INTEM Clotting Time
|
145.1 seconds
Standard Deviation 16.3
|
141.2 seconds
Standard Deviation 16.4
|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
Before Surgery EXTEM Clotting Time
|
54.0 seconds
Standard Deviation 5.1
|
56.1 seconds
Standard Deviation 7.2
|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
After Delivery EXTEM Clotting Time
|
54.9 seconds
Standard Deviation 6.3
|
56.3 seconds
Standard Deviation 8.0
|
|
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
P.O.D. 1 EXTEM Clotting Time
|
49.3 seconds
Standard Deviation 5.3
|
50.2 seconds
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).
Outcome measures
| Measure |
Tranexamic Acid
n=55 Participants
Participants received two doses (1 gram) of tranexamic acid diluted in 100 mL of normal saline. Tranexamic acid was given intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
Placebo
n=55 Participants
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
|
|---|---|---|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
Before Surgery INTEM Maximum Clot Firmness
|
69.3 millimeter
Standard Deviation 3.3
|
69.4 millimeter
Standard Deviation 3.7
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
After Delivery INTEM Maximum Clot Firmness
|
68.9 millimeter
Standard Deviation 3.2
|
68.4 millimeter
Standard Deviation 5.5
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
Before Surgery EXTEM Maximum Clot Firmness
|
70.8 millimeter
Standard Deviation 3.1
|
71.2 millimeter
Standard Deviation 3.5
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
P.O.D. 1 INTEM Maximum Clot Firmness
|
68.8 millimeter
Standard Deviation 3.1
|
68.8 millimeter
Standard Deviation 3.8
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
After Delivery EXTEM Maximum Clot Firmness
|
69.8 millimeter
Standard Deviation 3.1
|
69.6 millimeter
Standard Deviation 5.5
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
P.O.D. 1 EXTEM Maximum Clot Firmness
|
70.5 millimeter
Standard Deviation 2.8
|
70.4 millimeter
Standard Deviation 4.0
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
Before Surgery FIBTEM Maximum Clot Firmness
|
24.2 millimeter
Standard Deviation 3.8
|
23.9 millimeter
Standard Deviation 4.8
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
After Delivery FIBTEM Maximum Clot Firmness
|
22.5 millimeter
Standard Deviation 4.1
|
22.0 millimeter
Standard Deviation 4.4
|
|
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
P.O.D. 1 FIBTEM Maximum Clot Firmness
|
25.8 millimeter
Standard Deviation 4.7
|
25.0 millimeter
Standard Deviation 5.0
|
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place