Expired Study
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Houston, Texas 77030


Purpose:

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).


Study 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 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.


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.


Study is Available At:


Original ID:

H-41847


NCT ID:

NCT02329756


Secondary ID:

H-41847


Study Acronym:


Brief Title:

Tranexamic Acid in Adherent Placenta (TAP)


Official Title:

Tranexamic Acid in Adherent Placenta (TAP), a Randomized Clinical Trial


Overall Status:

Withdrawn


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

More preparation needed prior to collecting


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael A Belfort, MD, PhD
Principal Investigator
Baylor College of Medicine

Study Dates

Start Date:December 2018
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:December 2020
Primary Completion Type:Anticipated
Verification Date:August 2018
Last Changed Date:August 21, 2018
First Received Date:December 29, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Thromboembolic events
Time Frame:From time patient is given treatment up to 12 weeks post-partum.
Safety Issues:False
Description:Data from all thromboembolic events will be documented on CRFs, including but not limited to the amount and severity of events.
Outcome Type:Primary Outcome
Measure:Hemoglobin level change post surgery
Time Frame:At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Safety Issues:False
Description:The level of hemoglobin change will be measured after surgery.
Outcome Type:Primary Outcome
Measure:Blood product requirements
Time Frame:At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Safety Issues:False
Description:The administration of a fixed dose is more practicable in this study and we have thus selected a fixed dose of 1 gram of TXA 10 minutes prior to induction of anesthesia, followed by a second dose of 1 gram if heavy bleeding is encountered 30 or more minut
Outcome Type:Primary Outcome
Measure:Estimated blood loss (EBL)
Time Frame:At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first
Safety Issues:False
Description:Our data from the past 65 cases of MAPL performed by our team over the past 3 years shows a 2500 +/- 500ml mean blood loss with these surgeries. Using pooled estimates of the reduction in blood loss published in the literature, a 30% reduction is a reason

Study Interventions

Intervention Type:Drug
Name:Tranexamic Acid (TXA)
Description:1g Tranexamic Acid (TXA) will be given at the time of delivery. If in 30 minutes, heavy bleeding continues, a 2nd dose will be administered.
Arm Name:Treatment
Other Name:Cyklokapron
Intervention Type:Drug
Name:Sodium Chloride 0.9%
Description: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
Arm Name:Control
Other Name:NaCl

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Control
Description:Matching placebo (sodium chloride 0.9%) will be compared with treatment group
Study Arm Type:Active Comparator
Arm Name:Treatment
Description:Tranexamic acid (TXA) will be compared with matching placebo (sodium chloride 0.9%).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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