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

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ClinicalTrials.gov Identifier: NCT03856164
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
Blood volume loss [ Time Frame: 24 hours postpartum. ]
Total blood volume lost will be calculated in milliliters.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
Blood volume loss [ Time Frame: One day postpartum ]
Total blood volume lost will be calculated in milliliters.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Fibrinogen (mg/dL) [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.
  • D-Dimer (mcg/mL fibrinogen equivalent units) [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.
  • Tissue Plasminogen Activator Antigen (ng/mL) [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.
  • Plasminogen Activator Inhibitor-Type-1 (Units/mL) [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.
  • Rotational Thromboelastometry (ROTEM) Values [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Fibrinogen (mg/dL) [ Time Frame: One day postpartum ]
    Blood samples collected prior to study infusions, immediately following second infusion and one day postpartum.
  • D-Dimer (mcg/mL fibrinogen equivalent units) [ Time Frame: One day postpartum ]
    Blood samples collected prior to study infusions, immediately following second infusion and one day postpartum.
  • Tissue Plasminogen Activator Antigen (ng/mL) [ Time Frame: One day postpartum ]
    Blood samples collected prior to study infusions, immediately following second infusion and one day postpartum.
  • Plasminogen Activator Inhibitor-Type-1 (Units/mL) [ Time Frame: One day postpartum ]
    Blood samples collected prior to study infusions, immediately following second infusion and one day postpartum.
  • Rotational Thromboelastometry (ROTEM) Values [ Time Frame: One day postpartum ]
    Blood samples collected prior to study infusions, immediately following second infusion and one day postpartum.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Official Title  ICMJE Use of Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Brief Summary The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.
Detailed Description

Obstetric hemorrhage has been identified as a contributory cause for the United States' suboptimal and inequitable outcomes among pregnant women. As such, obstetric hemorrhage has become a formal focus point in a national agenda to improve maternal outcomes. Strategies to identify maternal hypovolemia and treating obstetric hemorrhage are undergoing organized scrutiny in many states including Texas. Tranexamic acid (TXA) treatment is receiving increased emphasis in obstetric care because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prophylaxis) as well as mitigating ongoing hemorrhage. TXA therapy has been principally studied in nonpregnant populations; results of studies in pregnant women have been lacking.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in a variety of circumstances primarily involving trauma patients. Shakur and co-authors in a trial of 20,000 non-pregnant trauma patients reported a significant reduction in all-cause mortality after TXA administration. In another large study (WOMAN Trial), 20,000 pregnant women with hemorrhage were randomized to TXA or placebo. TXA was associated with a significant decrease in death due to bleeding.

Tranexamic acid's role in treating hemorrhage have been widely studied in non-pregnant populations. Studies of TXA in obstetrics are limited. The American College of Obstetricians and Gynecologists believes the data is insufficient to recommend tranexamic acid for prophylaxis.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing prior to incision for cesarean delivery with a repeat dose given at placental delivery. The purpose is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The investigators elected to study scheduled elective cesareans because such procedures are at low risk for profound hemorrhage. It is the intent to have a study cohort where the two treatment groups (TXA or placebo) are as comparable as possible, so the efficacy of TXA is not tested in women with highly variable volumes of obstetric hemorrhage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Post Partum Hemorrhage
  • Fibrinolysis; Hemorrhage
  • Blood Loss
Intervention  ICMJE
  • Drug: 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.
    Other Name: Cyklokapron
  • Drug: Placebo
    100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
    Other Name: Normal Saline
Study Arms  ICMJE
  • Active Comparator: Tranexamic acid
    Tranexamic Acid for intravenous administration.
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Placebo
    Normal saline for intravenous administration.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Intrauterine pregnancy
  2. Age ≥ 18
  3. Gestation age ≥ 37 weeks 0 days
  4. Scheduled cesarean delivery
  5. Second or third cesarean delivery
  6. Singleton pregnancy

Exclusion Criteria:

  1. First cesarean delivery
  2. Four or more cesarean deliveries
  3. Intrauterine fetal death
  4. Fetal anomalies
  5. Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
  6. Thrombocytopenia (Platelet count < 100k)
  7. Internal bleeding, external bleeding, easy bruising
  8. History of thrombotic event
  9. Hypertension
  10. Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)
  11. Insulin-treated diabetes
  12. Suspected morbidly adherent placenta
  13. Placenta previa
  14. Multiple Gestations
  15. BMI ≥ 50
  16. Hematocrit ≤ 25
  17. Blood transfusion within 24 hours prior to cesarean delivery
  18. History of abnormal bleeding or blood disorder
  19. Planned general anesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Olutoyosi Ogunkua, M.D. 214-648-6400 olutoyosi.ogunkua@utsouthwestern.edu
Contact: Lisa Moseley, R.N. 214-648-2591 lisa.moseley@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03856164
Other Study ID Numbers  ICMJE STU-2018-0315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olutoyosi Ogunkua, M.D. UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP