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Trial record 3 of 5 for:    25103301 [PUBMED-IDS]

Prevention of Postpartum Hemorrhage With TXA (TXA)

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ClinicalTrials.gov Identifier: NCT03326596
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Maureen Farrell, United States Naval Medical Center, San Diego

Brief Summary:
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid 1000 mg/10ml normal saline infusion Phase 4

Detailed Description:

Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of interventions developed to actively manage the third stage of labor, 27.1% of maternal deaths were directly attributable to excessive blood loss.

Risk factors for postpartum hemorrhage (PPH) have been identified, but the majority of cases occur in low risk women. As such, the routine use of oxytocin in the third stage of labor is recommended in all women and has been well documented to reduce the risk of excessive blood loss. Uterotonics such as methylergonovine, 15-methyl PGF2α and misoprostol have shown to be particularly useful adjuncts as decreased uterine tone is the most common etiology of blood loss. More recently, tranexamic acid (TXA) has been shown to be efficacious in the prevention of postpartum hemorrhage in certain cohorts.

Tranexamic acid exerts its effect through the binding of plasmin and subsequent inhibition of fibrin degradation. It is regarded as pregnancy category B by the Food and Drug Administration (FDA).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ProphylacticTranexamic Acid
Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.
Drug: Tranexamic Acid 1000 mg/10ml normal saline infusion
Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
Other Name: Cyklokapron




Primary Outcome Measures :
  1. Incidence of postpartum hemorrhage [ Time Frame: Up to six weeks from date of delivery ]
    Postpartum hemorrhage


Secondary Outcome Measures :
  1. Postpartum blood loss [ Time Frame: Up to six weeks from date of delivery ]
    Estimated blood loss (EBL)

  2. Percent decrease in hematocrit [ Time Frame: 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery ]
    Hematocrit percentage

  3. Number of units of packed red blood cells transfused [ Time Frame: Up to six weeks from date of delivery ]
    Number of units of packed red blood cells transfused

  4. Number of units of platelets transfused [ Time Frame: Up to six weeks from date of delivery ]
    Number of units of platelets transfused

  5. Number of units of fresh frozen plasma transfused [ Time Frame: Up to six weeks from date of delivery ]
    Number of units of fresh frozen plasma transfused

  6. Number of units of cryoprecipitate transfused [ Time Frame: Up to six weeks from date of delivery ]
    Number of units of cryoprecipitate transfused

  7. Amount of methylergonovine administered [ Time Frame: Up to six weeks from date of delivery ]
    Amount of methylergonovine administered

  8. Amount of 15-methyl prostaglandin F2(PGF2) administered [ Time Frame: Up to six weeks from date of delivery ]
    Amount of 15-methyl prostaglandin F2(PGF2) administered

  9. Amount of misoprostol administered [ Time Frame: Up to six weeks from date of delivery ]
    Amount of misoprostol administered

  10. Amount of oxytocin administered [ Time Frame: Up to six weeks from date of delivery ]
    Amount of oxytocin administered

  11. Exploratory laparotomy following vaginal delivery due to hemorrhage [ Time Frame: Up to six weeks from date of delivery ]
    Exploratory laparotomy, no hysterectomy

  12. Exploratory laparotomy following cesarean delivery due to hemorrhage [ Time Frame: Up to six weeks from date of delivery ]
    Exploratory laparotomy, no hysterectomy

  13. Hysterectomy [ Time Frame: Up to six weeks from date of delivery ]
    Number of hysterectomies performed as a result of postpartum hemorrhage

  14. Intensive Care Unit (ICU) admission [ Time Frame: Up to six weeks from date of delivery ]
    Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage

  15. Maternal thromboembolic events [ Time Frame: up to six weeks from date of delivery ]
    Incidence of maternal thromboembolic events

  16. Diagnosis of intraventricular hemorrhage in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome intraventricular hemorrhage

  17. Diagnosis of anemia in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome anemia

  18. Diagnosis of disseminated intravascular coagulation (DIC) in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome DIC

  19. Diagnosis of neonatal sepsis [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome sepsis

  20. Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome HIE

  21. Diagnosis of a seizure disorder in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome seizure disorder

  22. Diagnosis of arrhythmia in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome arrhythmia

  23. Diagnosis of heart failure in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome heart failure

  24. Diagnosis of renal failure in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome renal failure

  25. Diagnosis of hepatic failure in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome hepatic failure

  26. Diagnosis of thromboembolic events in the neonate [ Time Frame: Up to six weeks from date of delivery ]
    Neonatal outcome thromboembolic event

  27. Maternal mortality [ Time Frame: Up to six weeks from date of delivery ]
    Incidence of maternal mortality

  28. Additional tranexamic acid administered [ Time Frame: Up to six weeks from date of delivery ]
    Additional tranexamic acid administered

  29. Rate of Bakri/balloon tamponade use [ Time Frame: Up to six weeks from date of delivery ]
    Bakri/balloon tamponade use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant female presenting to Navy Medical Center San Diego for delivery
  • Able to speak and understand English
  • Planning to deliver at NMCSD

Exclusion Criteria:

  • Age less than 18 years
  • Unable to speak or understand English
  • Not planning to deliver at NMCSD
  • Planned cesarean hysterectomy
  • Current anticoagulant use
  • Current subarachnoid hemorrhage
  • Any active/current intravascular clotting (i.e. venous thromboembolic events)
  • Patients with a hypersensitivity to TXA or any of the ingredients
  • Personal history of venous or arterial thrombotic events
  • Conditions that predispose patients to thromboembolic events (e.g. thrombophilias, autoimmune diseases such as lupus, active cancer, congestive heart failure, family history of thrombosis in a first degree relative at age < 30 years) due to increased risk of thrombosis
  • Patients taking factor IX complex concentrates or anti-inhibitor coagulant concentrates (e.g. FEIBA NF)
  • Eclampsia or seizure disorder because the use of tranexamic acid has been associated with postoperative seizures
  • Patients with a baseline creatinine 1.2 or higher, history of renal insufficiency, or renal disease because of the risk of toxicity in patients with preexisting disease
  • Patients with frank hematuria because ureteral obstruction due to clot formation has been reported in patients with upper urinary tract bleeding who were treated with tranexamic acid
  • Patients with active or history of retinal diseases as cases of central retinal artery and central retinal vein obstruction have been reported in patients treated with intravenous tranexamic acid
  • Patients with acquired defective color vision

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): NCT03326596


Contacts
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Contact: Salvador I Doria 619-532-9927 salvador.i.doria.civ@mail.mil
Contact: Geri P Hollinger 619-532-9416 geri.p.hollinger.civ@mail.mil

Locations
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United States, California
Navy Medical Center Recruiting
San Diego, California, United States, 92134
Contact: Salvador I Doria    619-532-9927    salvador.i.doria.civ@mail.mil   
Contact: Geri P Hollinger    619-532-9416    geri.p.hollinger.civ@mail.mil   
Principal Investigator: Maureen E Farrell, MD         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Maureen E Farrell, MD United States Naval Medical Center, San Diego,CA
  Study Documents (Full-Text)

Documents provided by Maureen Farrell, United States Naval Medical Center, San Diego:
Informed Consent Form: Informed Consent  [PDF] September 10, 2017
Study Protocol: Protocol Cover Page  [PDF] September 10, 2017


Publications of Results:

Other Publications:
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Responsible Party: Maureen Farrell, Program Director, Obstetrics & Gynecology Residency, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT03326596     History of Changes
Other Study ID Numbers: NMCSD.2017.0034
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
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.: No
Keywords provided by Maureen Farrell, United States Naval Medical Center, San Diego:
Hemorrhage
Tranexamic acid (TXA)
Estimated Blood Loss (EBL)
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