Phase 3
N=11,000
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
Obstetrical Complications · Hemorrhage · Labor and Delivery
Bottom Line
View on ClinicalTrials.gov: NCT03364491 ↗Enrolled (actual)
11,000
Serious AEs
1.4%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells — 201; 233 Participants — p=0.19
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The George Washington University Biostatistics Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells |
201; 233 | 0.19 |
| SECONDARY Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery |
339; 368 | — |
| SECONDARY Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours |
35; 32 | — |
| SECONDARY Number of Participants Who Were Transfused With Other Blood Products |
29; 31 | — |
| SECONDARY Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells |
20; 19 | — |
| SECONDARY Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction |
12; 13 | — |
| SECONDARY Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment |
2; 0 | — |
| SECONDARY Number of Participants With Postpartum Infectious Complications |
162; 125 | — |
| SECONDARY Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin |
649; 732 | — |
| SECONDARY Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications |
233; 231 | — |
| SECONDARY Change in Hemoglobin |
-1.8; -1.9 | — |
| SECONDARY Number of Participants Who Received Open Label TXA or Other Antifibrinolytic |
108; 109 | — |
| SECONDARY Length of Stay |
3; 3 | — |
| SECONDARY Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications |
892; 986 | — |
Summary
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
Eligibility Criteria
Inclusion Criteria
- Scheduled or unscheduled cesarean delivery
- Singleton or twin gestation
Exclusion Criteria
- Age less than 18 years
- Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage
- Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
- Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
- Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
- Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions.
- Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
- Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
- Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
- Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
- Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
- Patient refusal of blood products because the primary outcome is then pre-determined
- Receipt of TXA; or planned or expected use of TXA prophylaxis
- Active cancer, because of risk of thromboembolism
- Congestive heart failure requiring treatment, because of risk of thrombosis
- History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA
- Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated
- Hypersensitivity to TXA or any of the ingredients
- No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
- Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on the number of scheduled and unscheduled deliveries will be placed to ensure approximately equal distribution of scheduled and unscheduled cesarean deliveries.
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
- Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
- Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
- Symptomatic for COVID-19 infection within 14 days prior to delivery
Data sourced from ClinicalTrials.gov (NCT03364491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.