Community Regional Medical Center
Fresno, California, 93721, United States
NCT Number: NCT02806024
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
Looking for future studies?
Notify Me18 year–60 year
Female
Interventional
Phase 4
Fresno, California, 93721, United States
To date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. There has been growing interest in the application of tranexamic acid in obstetrics and gynecology. In multiple international studies, intravenous TXA has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. TXA has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 cc Normal Saline IV
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).
Time frame: Pulled from operative note, completed by the time of discharge.
Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome.
University of California, San Francisco
Other
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
Acronym: TAPPAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06253832
Blood Loss Massive, Female Urogenital Diseases and Pregnancy Complications
Manouba, Tunis Governorate, Tunisia
View Trial DetailsNCT05938062
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Istanbul, Basaksehir, Turkey (Türkiye)
View Trial DetailsNCT04660578
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT03707132
Blood Loss Massive, Female Urogenital Diseases and Pregnancy Complications
View Trial Details