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
|Condition or disease||Intervention/treatment||Phase|
|Post Partum Hemorrhage Fibrinolysis; Hemorrhage Blood Loss||Drug: Tranexamic Acid Drug: Placebo||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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
- Blood volume loss [ Time Frame: 24 hours postpartum. ]Total blood volume lost will be calculated in milliliters.
- 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.
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
|Contact: Olutoyosi Ogunkua, M.D.||firstname.lastname@example.org|
|Contact: Lisa Moseley, R.N.||email@example.com|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Contact: Lisa Moseley, RN|
|Principal Investigator:||Olutoyosi Ogunkua, M.D.||UT Southwestern|