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Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery (TXA)

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ClinicalTrials.gov Identifier: NCT03856164
Recruitment Status : Completed
First Posted : February 27, 2019
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Olutoyosi Ogunkua, MD, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Post Partum Hemorrhage
Fibrinolysis; Hemorrhage
Blood Loss
Interventions Drug: Tranexamic Acid
Drug: Placebo
Enrollment 110
Recruitment Details 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.
Pre-assignment Details Of the 110 enrolled participants, all met inclusion criteria and were randomized.
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description 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. Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Period Title: Overall Study
Started 55 55
Completed 55 55
Not Completed 0 0
Arm/Group Title Tranexamic Acid Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
29.8  (5.2) 28.7  (5.2) 29.3  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
55
 100.0%
55
 100.0%
110
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Black, non-Hispanic
1
   1.8%
9
  16.4%
10
   9.1%
White, non-Hispanic
2
   3.6%
0
   0.0%
2
   1.8%
Hispanic
52
  94.5%
46
  83.6%
98
  89.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 55 participants 110 participants
55 55 110
Parity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Parity = 1
26
  47.3%
23
  41.8%
49
  44.5%
Parity = 2
26
  47.3%
27
  49.1%
53
  48.2%
Parity = 3
1
   1.8%
3
   5.5%
4
   3.6%
Parity = 4
1
   1.8%
2
   3.6%
3
   2.7%
Parity = 5
1
   1.8%
0
   0.0%
1
   0.9%
Body Mass Index (kg/m^2)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
< 25
1
   1.8%
3
   5.5%
4
   3.6%
25 - < 30
17
  30.9%
16
  29.1%
33
  30.0%
30 - < 35
17
  30.9%
16
  29.1%
33
  30.0%
35 - < 40
10
  18.2%
13
  23.6%
23
  20.9%
> =40
10
  18.2%
7
  12.7%
17
  15.5%
1.Primary Outcome
Title Blood Volume Loss
Hide Description Total blood volume loss will be calculated in milliliters.
Time Frame 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
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.
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: milliliters
2274  (469) 2407  (388)
2.Secondary Outcome
Title D-Dimer (µg/mL)
Hide Description Measured from blood sample collection.
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
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.
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: µg/mL
Before Surgery 2.9  (1.5) 4.0  (5.3)
After Delivery 2.4  (1.3) 3.8  (4.7)
P.O.D. 1 2.1  (1.2) 4.3  (2.4)
3.Secondary Outcome
Title Fibrinogen (mg/dL)
Hide Description Measured from blood sample collection.
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
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.
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
Before Surgery 563.5  (83.9) 550.7  (68.2)
After Delivery 499.6  (77) 484.9  (82.5)
P.O.D. 1 527.4  (69.8) 525.4  (86.1)
4.Secondary Outcome
Title Tissue Plasminogen Activator Antigen (ng/mL)
Hide Description Measured from blood sample collection.
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
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.
Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng/mL
Before Surgery 8.1  (3.6) 8.2  (2.7)
After Delivery 9.0  (3.7) 9.6  (2.9)
P.O.D. 1 7.5  (3.7) 7.4  (3.3)
5.Secondary Outcome
Title Plasminogen Activator Inhibitor-Type-1 (Units/mL)
Hide Description Measured from blood sample collection.
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: IU/mL
Before Surgery 81.8  (34.7) 61.7  (33.8)
After Delivery 67.0  (32.3) 63.3  (31.9)
P.O.D. 1 20.7  (26.7) 22.1  (28.5)
6.Secondary Outcome
Title Rotational Thromboelastometry INTEM and EXTEM Clotting Time
Hide Description 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).
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: seconds
Before Surgery INTEM Clotting Time 149.7  (14.4) 150.5  (14.2)
After Delivery INTEM Clotting Time 137.4  (18.3) 140.7  (29.9)
P.O.D. 1 INTEM Clotting Time 145.1  (16.3) 141.2  (16.4)
Before Surgery EXTEM Clotting Time 54.0  (5.1) 56.1  (7.2)
After Delivery EXTEM Clotting Time 54.9  (6.3) 56.3  (8.0)
P.O.D. 1 EXTEM Clotting Time 49.3  (5.3) 50.2  (6.9)
7.Secondary Outcome
Title Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
Hide Description 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).
Time Frame Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: millimeter
Before Surgery INTEM Maximum Clot Firmness 69.3  (3.3) 69.4  (3.7)
After Delivery INTEM Maximum Clot Firmness 68.9  (3.2) 68.4  (5.5)
P.O.D. 1 INTEM Maximum Clot Firmness 68.8  (3.1) 68.8  (3.8)
Before Surgery EXTEM Maximum Clot Firmness 70.8  (3.1) 71.2  (3.5)
After Delivery EXTEM Maximum Clot Firmness 69.8  (3.1) 69.6  (5.5)
P.O.D. 1 EXTEM Maximum Clot Firmness 70.5  (2.8) 70.4  (4.0)
Before Surgery FIBTEM Maximum Clot Firmness 24.2  (3.8) 23.9  (4.8)
After Delivery FIBTEM Maximum Clot Firmness 22.5  (4.1) 22.0  (4.4)
P.O.D. 1 FIBTEM Maximum Clot Firmness 25.8  (4.7) 25.0  (5.0)
Time Frame During patient admission, minimum of 3 days.
Adverse Event Reporting Description Only serious adverse events were collected according to the study protocol
 
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description 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. Participants received 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
All-Cause Mortality
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%) 
Hide Serious Adverse Events
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Olutoyosi Ogunkua
Organization: University of Texas Southwestern
Phone: 2145578873
EMail: olutoyosi.ogunkua@utsouthwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Olutoyosi Ogunkua, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03856164    
Other Study ID Numbers: STU-2018-0315
First Submitted: February 21, 2019
First Posted: February 27, 2019
Results First Submitted: November 11, 2020
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021