Tranexamic Acid in Adherent Placenta (TAP)

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.

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.