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NCT02026297 · ClinicalTrials.gov registry record · Phase 2
Tranexamic Acid and Thromboelastography During Cesarean Delivery
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT02026297 is a Phase 2 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 60 participants.
The verdict
NCT02026297, a Phase 2 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean delivery, and 2 hours postpartum. Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing interest in multimodal approaches to blood conservation during cesarean delivery. Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not been elucidated. This study will be conducted as a randomized, double-blind, controlled trial with two study arms: control (60 patients); and treatment (60 patients). Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured throughout surgery as per standard of care. Patients will all receive IV lactated Ringers' (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general anesthesia conversion, general anesthesia planned), i
Interventions
- DRUG Tranexamic Acid
- DRUG Placebo; Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-07 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02026297
The ClinicalTrials.gov registry entry for NCT02026297 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tranexamic Acid is the first listed.
NCT02026297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02026297 about?
NCT02026297 is a clinical study titled "Tranexamic Acid and Thromboelastography During Cesarean Delivery". The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during e...
What is the current status of trial NCT02026297?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-07. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02026297?
The interventions under investigation include: Tranexamic Acid (DRUG), Placebo; Normal Saline (DRUG).
Who is sponsoring clinical trial NCT02026297?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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