Overview

This trial is not yet open for recruitment.

Condition placenta accreta
Treatments tranexamic acid (txa), sodium chloride 0.9%
Phase phase 3
Sponsor Baylor College of Medicine
Start date July 2017
End date December 2020
Trial size 20 participants
Trial identifier NCT02329756, Baylor College of Medicine

Summary

The objective of this study is to investigate the effect of tranexamic acid (TXA) administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly Adherent Placenta (MAP; placenta accreta, increta, percreta).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose prevention
Masking investigator, outcomes assessor
Arm
(Active Comparator)
Tranexamic acid will be compared with matching placebo (sodium chloride 0.9%).
tranexamic acid (txa) Cyklokapron
1g Tranexamic acid will be given at the time of delivery. If in 30 minutes, heavy bleeding continues, a 2nd dose will be administered.
(Placebo Comparator)
Matching placebo (sodium chloride 0.9%) will be compared with treatment group
sodium chloride 0.9% NaCl
Dose 1: 1 gram - to be administered by intravenous injection at an approximate rate of 1 mL/minute to all randomized women approximately 10 minutes prior to induction of anesthesia Dose 2: 1 gram - If 30 minutes after beginning the cesarean section there is significant bleeding as defined by the need for the transfusion of 4 or more units of blood products, or if there is a rebleed within the 24 hours after the first dose, a second dose may be given. To be administered by intravenous injection at an approximate rate of 1 mL/minute. The trial treatment injections should not be mixed with blood for transfusion, or infusion solutions containing penicillin or mannitol.

Primary Outcomes

Measure
estimated blood loss (EBL)
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first

Secondary Outcomes

Measure
blood product requirements
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first
hemoglobin level change post surgery
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first

Eligibility Criteria

Female participants from 18 years up to 60 years old.

Inclusion Criteria

  • Ultrasound and/or MRI diagnosed MAPL pregnancy scheduled to have a cesarean hysterectomy
  • The responsible clinician is substantially uncertain as to whether or not to use TXA
  • Consent has been given according to approved procedures

Exclusion Criteria

  • Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized
  • Prior known thromboembolic event during pregnancy
  • Known contraindication to TXA (prior adverse reaction)
  • Patient unable to give adequate consent due to emergent cesarean hysterectomy
  • Bleeding prior to incision
  • Prior known thromboembolic event
  • Women with a history of any acute venous or arterial thrombosis including retinal artery/retinal vein occlusion, cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism
  • History of decreased renal function, renal cortical disease, or significant renal tract disease.

Additional Information

Official title Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial
Principal investigator Michael A. Belfort, M.D, PhD
Description This trial is a randomized, double blind, placebo controlled trial to quantify the effects of the preoperative administration of tranexamic acid on estimated blood loss and blood product utilization in women undergoing cesarean-hysterectomy for suspected MAP. Subgroup analyses will be performed for laboratory results (coagulation studies, electrolytes, complete blood count), urine output, hemodynamic parameters, return to OR for continued bleeding, post-operative complications (thromboembolism, wound separation, infection, fever), and length of hospital stay. Eligible patients will be randomized to receive either TXA or placebo. Women eligible for inclusion will be identified during their prenatal course or on admission to the hospital prior to surgery. They will be offered participation in the study after appropriate counseling regarding the equipoise regarding TXA and its use in pregnancy, and following a question and answer period they will be consented, and assigned a study number. A randomization table will be generated by the Texas Children's Hospital Investigational Pharmacy, using balanced blocks of 8, and will maintain control of the randomization to ensure blinding of participants and the clinical investigators. Randomization will occur when an order for study medication will be sent on a paper requisition to the Texas Children's Hospital Investigational Pharmacy, and a randomization number will be assigned to correspond to the study number. Ideally, this order will be sumbitted 24h prior to scheduled surgery, but may be submitted for urgent cases by calling the Texas Children's Clinical Pharmacy, and delivering the paper requisition to the 7th Floor Main Pharmacy. The Investigational Pharmacy will prepare study medication (Tranexamic acid I.V. or Normal saline as placebo) as determined by the randomization. The medication (whether study medication or placebo) will be packaged in identical syringes. Sealed, opaque envelopes will be available to the PI or an assigned designee to permit unblinding (linking randomization number and study number) only in the event of a clinical emergency involving a study partipant during times at which the Investigational Pharmacy is closed (nights, weekends, holidays). Once a patient has been randomized, the outcome in hospital will be collected even if the study medication is interrupted or not actually given.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.