Clinical Trial: Tranexamic Acid in Adherent Placenta (TAP)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial
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 Summary:
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
Sponsor: Baylor College of Medicine
Current Primary Outcome: estimated blood loss (EBL) [ Time Frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first ]
Original Primary Outcome:
- estimated blood loss (EBL) [ Time Frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first ]
- 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 ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Baylor College of Medicine
Dates:
Date Received: December 29, 2014
Date Started: July 2017
Date Completion: June 2021
Last Updated: February 4, 2017
Last Verified: February 2017
