Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS)
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|ClinicalTrials.gov Identifier: NCT02806024|
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Placenta Accreta Postpartum Hemorrhage Cesarean Section Tranexamic Acid||Drug: Tranexamic Acid Drug: Placebo Drug||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||August 2018|
Experimental: Treatment Arm (Tranexamic Acid, or TXA)
Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.
Drug: Tranexamic Acid
Placebo Comparator: Placebo Arm
Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.
Drug: Placebo Drug
50 cc Normal Saline IV
- Estimated blood loss (EBL) [ Time Frame: 1-3 hours (will be determined at the completion of the surgery). ]EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy).
- Blood transfusion (number of units transfused) [ Time Frame: One week. The number of units given, if any, will be tallied at the time of hospital discharge, which should be less than a one week period (average length of stay is 4-5 days). ]Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) during the entire hospital admission is a secondary outcome.
- ICU admission [ Time Frame: One week. Total number of days spent in the ICU, if any, will be tallied at the time of hospital discharge, which should be less than a one week period (average length of stay is 4-5 days). ]A secondary outcome will be length of ICU admission post operatively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806024
|United States, California|
|Community Regional Medical Center|
|Fresno, California, United States, 93721|