Clinical trial NCT02329756: Tranexamic Acid in Adherent Placenta (TAP)
Official title: Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Placenta Accreta
Keywords: Tranexamic Acid
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated blood loss (EBL)
timeFrame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
measure: Blood product requirements
timeFrame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
measure: Hemoglobin level change post surgery
timeFrame: At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Secondary outcomes:
measure: Thromboembolic events
timeFrame: From time patient is given treatment up to 12 weeks post-partum.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Michael A Belfort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Karin A Fox, MD,MEd
role: PRINCIPAL_INVESTIGATOR
References: