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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001876 | U.S. NIH Grant/Contract | View source | |
| KL2TR001877 | U.S. NIH Grant/Contract | View source | |
| K23HL141640 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.
Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose of Tranexamic acid 5mg/kg will be administered. |
|
| Cohort 2 | Experimental | Dose of Tranexamic acid 10 mg/kg will be administered. |
|
| Cohort 3 | Experimental | Dose of Tranexamic acid 15 mg/kg will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Model Parameter Estimates | Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr). | Different time points ranging from surgery (T0) to 1 day postpartum. |
| Pharmacodynamics of Tranexamic Acid | PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50). | Different time points ranging from surgery (T0) to 1 day postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Intraoperative blood loss | During surgery |
| Safety Parameters | Safety parameters such as adverse events (including nausea/vomiting) and serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women in 3rd trimester of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Homa Ahmadzia, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Slota | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33248975 | Derived | Ahmadzia HK, Luban NLC, Li S, Guo D, Miszta A, Gobburu JVS, Berger JS, James AH, Wolberg AS, van den Anker J. Optimal use of intravenous tranexamic acid for hemorrhage prevention in pregnant women. Am J Obstet Gynecol. 2021 Jul;225(1):85.e1-85.e11. doi: 10.1016/j.ajog.2020.11.035. Epub 2020 Nov 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Dose of Tranexamic acid 5mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| FG001 | Cohort 2 | Dose of Tranexamic acid 10 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| FG002 | Cohort 3 | Dose of Tranexamic acid 15 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Dose of Tranexamic acid 5mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PK Model Parameter Estimates | Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr). | Groups are combined because in PKPD modeling the best model parameter estimates are determined from combination of individual participant data of the dose administered, patient characteristics, times of administration and drug level in plasma. | Posted | Geometric Mean | Standard Deviation | L/hr | Different time points ranging from surgery (T0) to 1 day postpartum. |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Dose of Tranexamic acid 5mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Homa K. Ahmadzia | GW University | 2027412500 | homa.khorrami@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2018 | Jan 29, 2024 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2023 | Aug 15, 2024 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2019 | Oct 27, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Three doses of Tranexamic acid (5 mg/kg, 10 mg/kg, and 15 mg/kg) will be used in a dose escalation fashion by cohort with the lowest dose first.
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|
| During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum |
Dose of Tranexamic acid 10 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| BG002 | Cohort 3 | Dose of Tranexamic acid 15 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 15 mg/kg | Dose group 3 |
|
|
| Primary | Pharmacodynamics of Tranexamic Acid | PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50). | Groups are combined because in PKPD modeling the best model parameter estimates are determined from combination of individual participant data of the dose administered, patient characteristics, times of administration and measured ML levels in plasma. | Posted | Geometric Mean | Standard Deviation | mg/L | Different time points ranging from surgery (T0) to 1 day postpartum. |
|
|
|
| Secondary | Estimated Blood Loss | Intraoperative blood loss | Posted | Median | Full Range | mL | During surgery |
|
|
|
| Secondary | Safety Parameters | Safety parameters such as adverse events (including nausea/vomiting) and serious adverse events | Posted | Number | events | During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Cohort 2 | Dose of Tranexamic acid 10 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG002 | Cohort 3 | Dose of Tranexamic acid 15 mg/kg will be administered. Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first. | 0 | 10 | 0 | 10 | 6 | 10 |
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
| blood in neonate's stool | Gastrointestinal disorders | Systematic Assessment |
|
| neonatal thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| facial rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |