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Trial record 4 of 5 for:    25103301 [PUBMED-IDS]

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

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.

Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Fibrinolysis; Hemorrhage Blood Loss Drug: Tranexamic Acid Drug: Placebo Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Use of Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid
Tranexamic Acid for intravenous administration.
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

Placebo Comparator: Placebo
Normal saline for intravenous administration.
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




Primary Outcome Measures :
  1. Blood volume loss [ Time Frame: 24 hours postpartum. ]
    Total blood volume lost will be calculated in milliliters.


Secondary Outcome Measures :
  1. Fibrinogen (mg/dL) [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.

  2. 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.

  3. 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.

  4. 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.

  5. Rotational Thromboelastometry (ROTEM) Values [ Time Frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum. ]
    Blood sample collected.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856164


Contacts
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Contact: Olutoyosi Ogunkua, M.D. 214-648-6400 olutoyosi.ogunkua@utsouthwestern.edu
Contact: Lisa Moseley, R.N. 214-648-2591 lisa.moseley@utsouthwestern.edu

Locations
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United States, Texas
Parkland Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Lisa Moseley, RN         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Olutoyosi Ogunkua, M.D. UT Southwestern

Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03856164     History of Changes
Other Study ID Numbers: STU-2018-0315
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Texas Southwestern Medical Center:
Tranexamic acid
TXA
Anti-fibrinolytics
Postpartum hemorrhage
Obstetric hemorrhage
Fibrinolysis
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants