Tranexamic Acid in Adherent Placenta (TAP)

NCT02329756 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: H-41847
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Placenta Accreta

Keywords

Tranexamic Acid

Outcome Measures

Primary Outcomes (3)

• Estimated blood loss (EBL)

  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 reasonable expectation.

  At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first

• Blood product requirements

  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 minutes after starting the cesarean section which requires the transfusion of 4 or more units of blood products. This is within the dose range which has been shown to inhibit fibrinolysis and provide hemostatic benefit.

  At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first

• Hemoglobin level change post surgery

  The level of hemoglobin change will be measured after surgery.

  At patient discharge, upon death or 6 weeks (42 days) after randomization, whichever occurs first

Secondary Outcomes (1)

• Thromboembolic events

  From time patient is given treatment up to 12 weeks post-partum.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Tranexamic acid (TXA) will be compared with matching placebo (sodium chloride 0.9%).

Drug: Tranexamic Acid (TXA)

Control

PLACEBO COMPARATOR

Matching placebo (sodium chloride 0.9%) will be compared with treatment group

Drug: Sodium Chloride 0.9%

Interventions

Tranexamic Acid (TXA) DRUG

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.

Also known as: Cyklokapron

Treatment

Sodium Chloride 0.9% DRUG

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.

Also known as: NaCl

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: The inclusion criteria includes pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael A Belfort, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Karin A Fox, MD,MEd

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug and placebo will be prepared by Investigational Pharmacy, and with similar appearing packaging and syringes. The Investigational Pharmacy will maintain the randomization table and allocation list. Participants, care providers, investigators and outcomes assessors will remain blinded until after data analysis completed, unless unblinding required in case of clinical emergency, per the unblinding procedures within the protocol.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 1, 2015
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)