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Trial record 8 of 432 for:    TRANEXAMIC ACID

Prevention of Postpartum Hemorrhage With Tranexamic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287336
Recruitment Status : Active, not recruiting
First Posted : September 19, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Homa Ahmadzia, George Washington University

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE September 19, 2017
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE January 2, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Pharmacokinetics of Tranexamic Acid [ Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum. ]
    Serum Assay of TXA in blood and breast milk to determine clearance.
  • Pharmacodynamics of Tranexamic acid [ Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum. ]
    Pharmacodynamics: maximum lysis (ML) and other coagulation markers such as d-dimer and plasmin-anti-plasmin complexes
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Pharmacokinetics of Tranexamic Acid [ Time Frame: Different time points ranging from surgery (T0) to 4 days postpartum (T4) ]
    Determined by measuring drug Clearance (CL) from serum- i.e. the elimination of the drug from the human body and calculated in milliliters per min (ml/min).
  • Pharmacodynamics of Tranexamic acid [ Time Frame: Different time points ranging from surgery (T0) to 4 days postpartum (T4) ]
    Two different measures will be assessed and combined to determine drug Pharmacodynamics: maximum clot firmness (MCF) and maximum lysis (ML)
Change History Complete list of historical versions of study NCT03287336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Estimated blood loss [ Time Frame: During surgery ]
    Intraoperative blood loss
  • Safety parameters [ Time Frame: During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum ]
    Safety parameters such as adverse events and serious adverse events
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Postpartum Hemorrhage With Tranexamic Acid
Official Title  ICMJE Prevention of Postpartum Hemorrhage: Identifying Pregnant Women at Risk and Determining the Safe and Effective Use of Tranexamic Acid Using State-of-the-art Pharmacokinetic/Pharmacodynamics Modeling
Brief Summary Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.
Detailed Description Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Three doses of Tranexamic acid (5 mg/kg, 10 mg/kg, and 15 mg/kg) will be used in a dose escalation fashion by cohort with the lowest dose first.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE Drug: Tranexamic Acid
Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
Other Name: TXA; Cyklokapron
Study Arms  ICMJE
  • Experimental: Cohort 1
    Dose of Tranexamic acid 5mg/kg will be administered.
    Intervention: Drug: Tranexamic Acid
  • Experimental: Cohort 2
    Dose of Tranexamic acid 10 mg/kg will be administered.
    Intervention: Drug: Tranexamic Acid
  • Experimental: Cohort 3
    Dose of Tranexamic acid 15 mg/kg will be administered.
    Intervention: Drug: Tranexamic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women who are undergoing medically indicated cesarean section at greater than 34+0 weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
  • Pregnant women with normal serum creatinine (serum creatinine < 0.9)
  • Women between the ages of 18 and 50 years old

Exclusion Criteria:

  • Patients younger than 18 or older than 50
  • women with active thrombotic or thromboembolic disease
  • Women with a history of arterial or venous thromboembolic event
  • Women with inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
  • Women with a subarachnoid hemorrhage
  • Women with acquired defective color vision
  • history of seizure disorder
  • known renal dysfunction
  • multiple gestations (Twin or triplet pregnancies)
  • Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
  • History of liver dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women in 3rd trimester of pregnancy
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03287336
Other Study ID Numbers  ICMJE IND134701
UL1TR001876 ( U.S. NIH Grant/Contract )
KL2TR001877 ( U.S. NIH Grant/Contract )
K23HL141640 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Homa Ahmadzia, George Washington University
Study Sponsor  ICMJE Homa Ahmadzia
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Homa Ahmadzia, MD George Washington University
PRS Account George Washington University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP