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Prevention of Postpartum Hemorrhage With TXA (TXA)

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid 1000 mg/10ml normal saline infusion
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Hemorrhage, Tranexamic acid (TXA), Estimated Blood Loss (EBL)

Eligibility Criteria

18 Years - 54 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Navy Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ProphylacticTranexamic Acid

Arm Description

Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.

Outcomes

Primary Outcome Measures

Incidence of postpartum hemorrhage
Postpartum hemorrhage

Secondary Outcome Measures

Postpartum blood loss
Estimated blood loss (EBL)
Percent decrease in hematocrit
Hematocrit percentage
Number of units of packed red blood cells transfused
Number of units of packed red blood cells transfused
Number of units of platelets transfused
Number of units of platelets transfused
Number of units of fresh frozen plasma transfused
Number of units of fresh frozen plasma transfused
Number of units of cryoprecipitate transfused
Number of units of cryoprecipitate transfused
Amount of methylergonovine administered
Amount of methylergonovine administered
Amount of 15-methyl prostaglandin F2(PGF2) administered
Amount of 15-methyl prostaglandin F2(PGF2) administered
Amount of misoprostol administered
Amount of misoprostol administered
Amount of oxytocin administered
Amount of oxytocin administered
Exploratory laparotomy following vaginal delivery due to hemorrhage
Exploratory laparotomy, no hysterectomy
Exploratory laparotomy following cesarean delivery due to hemorrhage
Exploratory laparotomy, no hysterectomy
Hysterectomy
Number of hysterectomies performed as a result of postpartum hemorrhage
Intensive Care Unit (ICU) admission
Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage
Maternal thromboembolic events
Incidence of maternal thromboembolic events
Diagnosis of intraventricular hemorrhage in the neonate
Neonatal outcome intraventricular hemorrhage
Diagnosis of anemia in the neonate
Neonatal outcome anemia
Diagnosis of disseminated intravascular coagulation (DIC) in the neonate
Neonatal outcome DIC
Diagnosis of neonatal sepsis
Neonatal outcome sepsis
Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate
Neonatal outcome HIE
Diagnosis of a seizure disorder in the neonate
Neonatal outcome seizure disorder
Diagnosis of arrhythmia in the neonate
Neonatal outcome arrhythmia
Diagnosis of heart failure in the neonate
Neonatal outcome heart failure
Diagnosis of renal failure in the neonate
Neonatal outcome renal failure
Diagnosis of hepatic failure in the neonate
Neonatal outcome hepatic failure
Diagnosis of thromboembolic events in the neonate
Neonatal outcome thromboembolic event
Maternal mortality
Incidence of maternal mortality
Additional tranexamic acid administered
Additional tranexamic acid administered
Rate of Bakri/balloon tamponade use
Bakri/balloon tamponade use

Full Information

First Posted
October 10, 2017
Last Updated
October 10, 2018
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03326596
Brief Title
Prevention of Postpartum Hemorrhage With TXA
Acronym
TXA
Official Title
Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Hemorrhage, Tranexamic acid (TXA), Estimated Blood Loss (EBL)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ProphylacticTranexamic Acid
Arm Type
Experimental
Arm Description
Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 1000 mg/10ml normal saline infusion
Other Intervention Name(s)
Cyklokapron
Intervention Description
Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
Primary Outcome Measure Information:
Title
Incidence of postpartum hemorrhage
Description
Postpartum hemorrhage
Time Frame
Up to six weeks from date of delivery
Secondary Outcome Measure Information:
Title
Postpartum blood loss
Description
Estimated blood loss (EBL)
Time Frame
Up to six weeks from date of delivery
Title
Percent decrease in hematocrit
Description
Hematocrit percentage
Time Frame
6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery
Title
Number of units of packed red blood cells transfused
Description
Number of units of packed red blood cells transfused
Time Frame
Up to six weeks from date of delivery
Title
Number of units of platelets transfused
Description
Number of units of platelets transfused
Time Frame
Up to six weeks from date of delivery
Title
Number of units of fresh frozen plasma transfused
Description
Number of units of fresh frozen plasma transfused
Time Frame
Up to six weeks from date of delivery
Title
Number of units of cryoprecipitate transfused
Description
Number of units of cryoprecipitate transfused
Time Frame
Up to six weeks from date of delivery
Title
Amount of methylergonovine administered
Description
Amount of methylergonovine administered
Time Frame
Up to six weeks from date of delivery
Title
Amount of 15-methyl prostaglandin F2(PGF2) administered
Description
Amount of 15-methyl prostaglandin F2(PGF2) administered
Time Frame
Up to six weeks from date of delivery
Title
Amount of misoprostol administered
Description
Amount of misoprostol administered
Time Frame
Up to six weeks from date of delivery
Title
Amount of oxytocin administered
Description
Amount of oxytocin administered
Time Frame
Up to six weeks from date of delivery
Title
Exploratory laparotomy following vaginal delivery due to hemorrhage
Description
Exploratory laparotomy, no hysterectomy
Time Frame
Up to six weeks from date of delivery
Title
Exploratory laparotomy following cesarean delivery due to hemorrhage
Description
Exploratory laparotomy, no hysterectomy
Time Frame
Up to six weeks from date of delivery
Title
Hysterectomy
Description
Number of hysterectomies performed as a result of postpartum hemorrhage
Time Frame
Up to six weeks from date of delivery
Title
Intensive Care Unit (ICU) admission
Description
Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage
Time Frame
Up to six weeks from date of delivery
Title
Maternal thromboembolic events
Description
Incidence of maternal thromboembolic events
Time Frame
up to six weeks from date of delivery
Title
Diagnosis of intraventricular hemorrhage in the neonate
Description
Neonatal outcome intraventricular hemorrhage
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of anemia in the neonate
Description
Neonatal outcome anemia
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of disseminated intravascular coagulation (DIC) in the neonate
Description
Neonatal outcome DIC
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of neonatal sepsis
Description
Neonatal outcome sepsis
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate
Description
Neonatal outcome HIE
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of a seizure disorder in the neonate
Description
Neonatal outcome seizure disorder
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of arrhythmia in the neonate
Description
Neonatal outcome arrhythmia
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of heart failure in the neonate
Description
Neonatal outcome heart failure
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of renal failure in the neonate
Description
Neonatal outcome renal failure
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of hepatic failure in the neonate
Description
Neonatal outcome hepatic failure
Time Frame
Up to six weeks from date of delivery
Title
Diagnosis of thromboembolic events in the neonate
Description
Neonatal outcome thromboembolic event
Time Frame
Up to six weeks from date of delivery
Title
Maternal mortality
Description
Incidence of maternal mortality
Time Frame
Up to six weeks from date of delivery
Title
Additional tranexamic acid administered
Description
Additional tranexamic acid administered
Time Frame
Up to six weeks from date of delivery
Title
Rate of Bakri/balloon tamponade use
Description
Bakri/balloon tamponade use
Time Frame
Up to six weeks from date of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador I Doria
Phone
619-532-9927
Email
salvador.i.doria.civ@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Geri P Hollinger
Phone
619-532-9416
Email
geri.p.hollinger.civ@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen E Farrell, MD
Organizational Affiliation
United States Naval Medical Center, San Diego,CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navy Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador I Doria
Phone
619-532-9927
Email
salvador.i.doria.civ@mail.mil
First Name & Middle Initial & Last Name & Degree
Geri P Hollinger
Phone
619-532-9416
Email
geri.p.hollinger.civ@mail.mil
First Name & Middle Initial & Last Name & Degree
Maureen E Farrell, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25103301
Citation
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
Results Reference
background
PubMed Identifier
21173639
Citation
Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
Results Reference
background
PubMed Identifier
23586122
Citation
WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
Results Reference
background
PubMed Identifier
25571934
Citation
Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
Results Reference
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PubMed Identifier
26079202
Citation
Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
Results Reference
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PubMed Identifier
26226243
Citation
Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.
Results Reference
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PubMed Identifier
26698831
Citation
Simonazzi G, Bisulli M, Saccone G, Moro E, Marshall A, Berghella V. Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2016 Jan;95(1):28-37. doi: 10.1111/aogs.12798. Epub 2015 Nov 12.
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PubMed Identifier
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Citation
Ker K, Shakur H, Roberts I. Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG. 2016 Oct;123(11):1745-52. doi: 10.1111/1471-0528.14267. Epub 2016 Aug 24.
Results Reference
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PubMed Identifier
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Citation
CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
Results Reference
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Citation
WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26. Erratum In: Lancet. 2017 May 27;389(10084):2104.
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Citation
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Citation
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Results Reference
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Prevention of Postpartum Hemorrhage With TXA

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