Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Central California Faculty Medical Group | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm (Tranexamic Acid, or TXA) | Experimental | 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. |
|
| Placebo Arm | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Placebo Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss (EBL) | EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy). | 1-3 hours (will be determined at the completion of the surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Transfusion (Number of Units Transfused) Intraoperatively | Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome. | Pulled from operative note, completed by the time of discharge. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Fresno | California | 93721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26079202 | Background | Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. | |
| 16738145 | Background | Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
One patient was excluded from the study after consenting to participate, but before delivery. Two consented patients delivered at night, and were unable to be randomized.
Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Tranexamic Acid |
| FG001 | 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. Placebo Drug: 50 cc Normal Saline IV |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Tranexamic Acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Blood Loss (EBL) | EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy). | Mean estimated blood loss (EBL) was calculated as below. | Posted | Mean | Standard Deviation | cc | 1-3 hours (will be determined at the completion of the surgery). |
|
Enrollment to 6 weeks post partum.
Patients were seen for routine post partum care and chart review was performed to glean adverse events from their hospital stay for delivery.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Tranexamic Acid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DVT / PE | Blood and lymphatic system disorders | DVT/PE | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract injury during surgery (cystotomy or ureter injury) | Renal and urinary disorders | GU injury intraop | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mallory Kremer | University of Washington | 206.616.5258 | mkremer@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2016 | Sep 14, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2016 | Nov 14, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
50 cc Normal Saline IV |
|
| 23574458 | Background | Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gulmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10. |
| BG001 | 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. Placebo Drug: 50 cc Normal Saline IV |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| 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. Placebo Drug: 50 cc Normal Saline IV |
|
|
| Secondary | Blood Transfusion (Number of Units Transfused) Intraoperatively | Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome. | The mean pRBCs units given intraoperatively is presented in the table below. | Posted | Mean | Standard Deviation | units | Pulled from operative note, completed by the time of discharge. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 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. Placebo Drug: 50 cc Normal Saline IV | 0 | 5 | 0 | 5 | 3 | 5 |
| Wound infection | Surgical and medical procedures | Wound seroma | Systematic Assessment | Post operative wound seroma |
|
| IR balloon complication | Surgical and medical procedures | IR balloon rupture | Systematic Assessment | Interventional radiology balloon complication |
|
Not provided
Not provided
Not provided
| D010922 | Placenta Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |