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Tranexamic Acid in Adherent Placenta (TAP)

NCT02329756 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-08-23

No results posted yet for this study

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

Interventions

DRUG

Tranexamic Acid (TXA)

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.

DRUG

Sodium Chloride 0.9%

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Michael A Belfort, MD, PhD · Baylor College of Medicine

  • Karin A Fox, MD,MEd · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329756 on ClinicalTrials.gov