NCT03856164

Brief Summary

The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

February 21, 2019

Results QC Date

November 11, 2020

Last Update Submit

January 12, 2021

Conditions

Post Partum HemorrhageFibrinolysis; HemorrhageBlood Loss

Keywords

Tranexamic acidTXAAnti-fibrinolyticsPostpartum hemorrhageObstetric hemorrhageFibrinolysis

Outcome Measures

Primary Outcomes (1)

  • Blood Volume Loss

    Total blood volume loss will be calculated in milliliters.

    24 hours postpartum.

Secondary Outcomes (6)

  • D-Dimer (µg/mL)

    Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  • Fibrinogen (mg/dL)

    Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  • Tissue Plasminogen Activator Antigen (ng/mL)

    Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  • Plasminogen Activator Inhibitor-Type-1 (Units/mL)

    Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  • Rotational Thromboelastometry INTEM and EXTEM Clotting Time

    Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  • +1 more secondary outcomes

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Tranexamic Acid for intravenous administration.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Normal saline for intravenous administration.

Drug: Placebo

Interventions

Tranexamic AcidDRUG

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.

Also known as: Cyklokapron
Tranexamic acid
PlaceboDRUG

100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.

Also known as: Normal Saline
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intrauterine pregnancy
  • Age ≥ 18
  • Gestation age ≥ 37 weeks 0 days
  • Scheduled cesarean delivery
  • Second or third cesarean delivery
  • Singleton pregnancy

You may not qualify if:

  • First cesarean delivery
  • Four or more cesarean deliveries
  • Intrauterine fetal death
  • Fetal anomalies
  • Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
  • Thrombocytopenia (Platelet count \< 100k)
  • Internal bleeding, external bleeding, easy bruising
  • History of thrombotic event
  • Hypertension
  • Diagnosis of renal insufficiency (Creatinine\> 1 mg/dL)
  • Insulin-treated diabetes
  • Suspected morbidly adherent placenta
  • Placenta previa
  • Multiple Gestations
  • BMI ≥ 50
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (18)

  • American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.

    PMID: 25545654BACKGROUND

  • 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/

    PMID: 23586122BACKGROUND

  • Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.

    PMID: 18819848BACKGROUND

  • GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2.

    PMID: 27733286BACKGROUND

  • 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.

    PMID: 28456509BACKGROUND

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

    PMID: 28937571BACKGROUND

  • Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6.

    PMID: 29490690BACKGROUND

  • Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

    PMID: 10400410BACKGROUND

  • Hernandez JS, Alexander JM, Sarode R, McIntire DD, Leveno KJ. Calculated blood loss in severe obstetric hemorrhage and its relation to body mass index. Am J Perinatol. 2012 Aug;29(7):557-60. doi: 10.1055/s-0032-1310528. Epub 2012 Apr 11.

    PMID: 22495893BACKGROUND

  • Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.

    PMID: 19459866BACKGROUND

  • Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.

    PMID: 16581405BACKGROUND

  • Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869.

    PMID: 26241269BACKGROUND

  • McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.

    PMID: 22397329BACKGROUND

  • Molina RL, Pace LE. A Renewed Focus on Maternal Health in the United States. N Engl J Med. 2017 Nov 2;377(18):1705-1707. doi: 10.1056/NEJMp1709473. No abstract available.

    PMID: 29091560BACKGROUND

  • 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.

    PMID: 25103301BACKGROUND

  • John M. Eisenberg Center for Clinical Decisions and Communications Science. Management of Postpartum Hemorrhage: Current State of the Evidence. 2016 Jul 12. In: Comparative Effectiveness Review Summary Guides for Clinicians [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007-. Available from http://www.ncbi.nlm.nih.gov/books/NBK379234/

    PMID: 27512800BACKGROUND

  • Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.

    PMID: 30134136BACKGROUND

  • Ogunkua OT, Duryea EL, Nelson DB, Eddins MM, Klucsarits SE, McIntire DD, Leveno KJ. Tranexamic acid for prevention of hemorrhage in elective repeat cesarean delivery-a randomized study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100573. doi: 10.1016/j.ajogmf.2022.100573. Epub 2022 Jan 15.

    PMID: 35038612DERIVED

MeSH Terms

Conditions

Postpartum HemorrhageHemorrhage

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Olutoyosi Ogunkua
Organization
University of Texas Southwestern
olutoyosi.ogunkua@utsouthwestern.edu
2145578873

Study Officials

  • Olutoyosi Ogunkua, M.D.

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 27, 2019

Study Start

June 17, 2019

Primary Completion

January 10, 2020

Study Completion

August 31, 2020

Last Updated

January 19, 2021

Results First Posted

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)