Postpartum HemorrhagePhase 4TXANCT03326596
Prevention of Postpartum Hemorrhage With TXA
A Phase 4 study testing Tranexamic Acid 1000 mg/10ml normal saline infusion in people with Postpartum Hemorrhage, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid 1000 mg/10ml normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant female presenting to Navy Medical Center San Diego for delivery
- Able to speak and understand English
- Planning to deliver at NMCSD
Who cannot join
- Age less than 18 years
- Unable to speak or understand English
- Not planning to deliver at NMCSD
- Planned cesarean hysterectomy
- Current anticoagulant use
- Current subarachnoid hemorrhage
Show all 16Show fewer
- Any active/current intravascular clotting (i.e. venous thromboembolic events)
- Patients with a hypersensitivity to TXA or any of the ingredients
- Personal history of venous or arterial thrombotic events
- Conditions that predispose patients to thromboembolic events (e.g. thrombophilias, autoimmune diseases such as lupus, active cancer, congestive heart failure, family history of thrombosis in a first degree relative at age < 30 years) due to increased risk of thrombosis
- Patients taking factor IX complex concentrates or anti-inhibitor coagulant concentrates (e.g. FEIBA NF)
- Eclampsia or seizure disorder because the use of tranexamic acid has been associated with postoperative seizures
- Patients with a baseline creatinine 1.2 or higher, history of renal insufficiency, or renal disease because of the risk of toxicity in patients with preexisting disease
- Patients with frank hematuria because ureteral obstruction due to clot formation has been reported in patients with upper urinary tract bleeding who were treated with tranexamic acid
- Patients with active or history of retinal diseases as cases of central retinal artery and central retinal vein obstruction have been reported in patients treated with intravenous tranexamic acid
- Patients with acquired defective color vision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.
Read the detailed description
Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of interventions developed to actively manage the third stage of labor, 27.1% of maternal deaths were directly attributable to excessive blood loss.
Risk factors for postpartum hemorrhage (PPH) have been identified, but the majority of cases occur in low risk women. As such, the routine use of oxytocin in the third stage of labor is recommended in all women and has been well documented to reduce the risk of excessive blood loss. Uterotonics such as methylergonovine, 15-methyl PGF2α and misoprostol have shown to be particularly useful adjuncts as decreased uterine tone is the most common etiology of blood loss. More recently, tranexamic acid (TXA) has been shown to be efficacious in the prevention of postpartum hemorrhage in certain cohorts.
Tranexamic acid exerts its effect through the binding of plasmin and subsequent inhibition of fibrin degradation. It is regarded as pregnancy category B by the Food and Drug Administration (FDA).
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid 1000 mg/10ml normal saline infusion
- Keywords
- Hemorrhage, Tranexamic acid (TXA), Estimated Blood Loss (EBL)
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 1000 mg/10ml normal saline infusionDrug
Also called Cyklokapron
Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
| Study group | Role | What they receive |
|---|---|---|
| ProphylacticTranexamic Acid | Experimental | Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder. Receives: Drug: Tranexamic Acid 1000 mg/10ml normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postpartum hemorrhage
Postpartum hemorrhage
Measured: Up to six weeks from date of delivery
Secondary outcomes (29)
Postpartum blood loss
Estimated blood loss (EBL)
Measured: Up to six weeks from date of delivery
Percent decrease in hematocrit
Hematocrit percentage
Measured: 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery
Number of units of packed red blood cells transfused
Number of units of packed red blood cells transfused
Measured: Up to six weeks from date of delivery
Number of units of platelets transfused
Number of units of platelets transfused
Measured: Up to six weeks from date of delivery
Number of units of fresh frozen plasma transfused
Number of units of fresh frozen plasma transfused
Measured: Up to six weeks from date of delivery
Number of units of cryoprecipitate transfused
Number of units of cryoprecipitate transfused
Measured: Up to six weeks from date of delivery
Amount of methylergonovine administered
Amount of methylergonovine administered
Measured: Up to six weeks from date of delivery
Amount of 15-methyl prostaglandin F2(PGF2) administered
Amount of 15-methyl prostaglandin F2(PGF2) administered
Measured: Up to six weeks from date of delivery
Amount of misoprostol administered
Amount of misoprostol administered
Measured: Up to six weeks from date of delivery
Amount of oxytocin administered
Amount of oxytocin administered
Measured: Up to six weeks from date of delivery
Exploratory laparotomy following vaginal delivery due to hemorrhage
Exploratory laparotomy, no hysterectomy
Measured: Up to six weeks from date of delivery
Exploratory laparotomy following cesarean delivery due to hemorrhage
Exploratory laparotomy, no hysterectomy
Measured: Up to six weeks from date of delivery
Hysterectomy
Number of hysterectomies performed as a result of postpartum hemorrhage
Measured: Up to six weeks from date of delivery
Intensive Care Unit (ICU) admission
Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage
Measured: Up to six weeks from date of delivery
Maternal thromboembolic events
Incidence of maternal thromboembolic events
Measured: up to six weeks from date of delivery
Diagnosis of intraventricular hemorrhage in the neonate
Neonatal outcome intraventricular hemorrhage
Measured: Up to six weeks from date of delivery
Diagnosis of anemia in the neonate
Neonatal outcome anemia
Measured: Up to six weeks from date of delivery
Diagnosis of disseminated intravascular coagulation (DIC) in the neonate
Neonatal outcome DIC
Measured: Up to six weeks from date of delivery
Diagnosis of neonatal sepsis
Neonatal outcome sepsis
Measured: Up to six weeks from date of delivery
Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate
Neonatal outcome HIE
Measured: Up to six weeks from date of delivery
Diagnosis of a seizure disorder in the neonate
Neonatal outcome seizure disorder
Measured: Up to six weeks from date of delivery
Diagnosis of arrhythmia in the neonate
Neonatal outcome arrhythmia
Measured: Up to six weeks from date of delivery
Diagnosis of heart failure in the neonate
Neonatal outcome heart failure
Measured: Up to six weeks from date of delivery
Diagnosis of renal failure in the neonate
Neonatal outcome renal failure
Measured: Up to six weeks from date of delivery
Diagnosis of hepatic failure in the neonate
Neonatal outcome hepatic failure
Measured: Up to six weeks from date of delivery
Diagnosis of thromboembolic events in the neonate
Neonatal outcome thromboembolic event
Measured: Up to six weeks from date of delivery
Maternal mortality
Incidence of maternal mortality
Measured: Up to six weeks from date of delivery
Additional tranexamic acid administered
Additional tranexamic acid administered
Measured: Up to six weeks from date of delivery
Rate of Bakri/balloon tamponade use
Bakri/balloon tamponade use
Measured: Up to six weeks from date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start20 Apr 2018
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: PI retired from Navy 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Sidrah Malik, United States Naval Medical Center, San Diego
- Investigators
- Maureen E Farrell, MD, Principal investigator, United States Naval Medical Center, San Diego,CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326596
- Sponsor's protocol ID
- NMCSD.2017.0034
- Acronym
- TXA
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2017
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
PubMed 21173639WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
PubMed 23586122Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
PubMed 25571934Novikova 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.
PubMed 26079202Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.
PubMed 26226243Simonazzi G, Bisulli M, Saccone G, Moro E, Marshall A, Berghella V. Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2016 Jan;95(1):28-37. doi: 10.1111/aogs.12798. Epub 2015 Nov 12.
PubMed 26698831Ker K, Shakur H, Roberts I. Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG. 2016 Oct;123(11):1745-52. doi: 10.1111/1471-0528.14267. Epub 2016 Aug 24.
PubMed 27558956CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
PubMed 28456509Bouet PE, Ruiz V, Legendre G, Gillard P, Descamps P, Sentilhes L. Policy of high-dose tranexamic acid for treating postpartum hemorrhage after vaginal delivery. J Matern Fetal Neonatal Med. 2016;29(10):1617-22. doi: 10.3109/14767058.2015.1056731. Epub 2015 Jun 29.
PubMed 26118386Sujata N, Tobin R, Kaur R, Aneja A, Khanna M, Hanjoora VM. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016 Jun;133(3):312-5. doi: 10.1016/j.ijgo.2015.09.032. Epub 2016 Feb 16.
PubMed 26952346
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
- ClinicalTrials.gov ID
- NCT03326596
- Acronym / sponsor ID
- TXA / NMCSD.2017.0034
- Conditions
- Postpartum Hemorrhage
- Keywords
- Hemorrhage, Tranexamic acid (TXA), Estimated Blood Loss (EBL)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI retired from Navy 2018
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.
Detailed description
Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of interventions developed to actively manage the third stage of labor, 27.1% of maternal deaths were directly attributable to excessive blood loss.
Risk factors for postpartum hemorrhage (PPH) have been identified, but the majority of cases occur in low risk women. As such, the routine use of oxytocin in the third stage of labor is recommended in all women and has been well documented to reduce the risk of excessive blood loss. Uterotonics such as methylergonovine, 15-methyl PGF2α and misoprostol have shown to be particularly useful adjuncts as decreased uterine tone is the most common etiology of blood loss. More recently, tranexamic acid (TXA) has been shown to be efficacious in the prevention of postpartum hemorrhage in certain cohorts.
Tranexamic acid exerts its effect through the binding of plasmin and subsequent inhibition of fibrin degradation. It is regarded as pregnancy category B by the Food and Drug Administration (FDA).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| ProphylacticTranexamic Acid | Experimental | Drug: Tranexamic Acid 1000 mg/10ml normal saline infusionOnce consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant female presenting to Navy Medical Center San Diego for delivery
- Able to speak and understand English
- Planning to deliver at NMCSD
Key exclusion criteria (16 listed)
- Age less than 18 years
- Unable to speak or understand English
- Not planning to deliver at NMCSD
- Planned cesarean hysterectomy
- Current anticoagulant use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid 1000 mg/10ml normal saline infusionAlso: CyklokapronInfusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant | Drug | ProphylacticTranexamic Acid |
Primary outcome
Incidence of postpartum hemorrhage
Time frame: Up to six weeks from date of delivery
Postpartum hemorrhage
29 secondary outcomes
Postpartum blood loss
Time frame: Up to six weeks from date of delivery
Percent decrease in hematocrit
Time frame: 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery
Number of units of packed red blood cells transfused
Time frame: Up to six weeks from date of delivery
Number of units of platelets transfused
Time frame: Up to six weeks from date of delivery
Number of units of fresh frozen plasma transfused
Time frame: Up to six weeks from date of delivery
Number of units of cryoprecipitate transfused
Time frame: Up to six weeks from date of delivery
Amount of methylergonovine administered
Time frame: Up to six weeks from date of delivery
Amount of 15-methyl prostaglandin F2(PGF2) administered
Time frame: Up to six weeks from date of delivery
Amount of misoprostol administered
Time frame: Up to six weeks from date of delivery
Amount of oxytocin administered
Time frame: Up to six weeks from date of delivery
Exploratory laparotomy following vaginal delivery due to hemorrhage
Time frame: Up to six weeks from date of delivery
Exploratory laparotomy following cesarean delivery due to hemorrhage
Time frame: Up to six weeks from date of delivery
Hysterectomy
Time frame: Up to six weeks from date of delivery
Intensive Care Unit (ICU) admission
Time frame: Up to six weeks from date of delivery
Maternal thromboembolic events
Time frame: up to six weeks from date of delivery
Diagnosis of intraventricular hemorrhage in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of anemia in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of disseminated intravascular coagulation (DIC) in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of neonatal sepsis
Time frame: Up to six weeks from date of delivery
Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of a seizure disorder in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of arrhythmia in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of heart failure in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of renal failure in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of hepatic failure in the neonate
Time frame: Up to six weeks from date of delivery
Diagnosis of thromboembolic events in the neonate
Time frame: Up to six weeks from date of delivery
Maternal mortality
Time frame: Up to six weeks from date of delivery
Additional tranexamic acid administered
Time frame: Up to six weeks from date of delivery
Rate of Bakri/balloon tamponade use
Time frame: Up to six weeks from date of delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Background: PubMed 21173639Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
- Background: PubMed 23586122WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
- Results publication: PubMed 25571934Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
- Results publication: PubMed 26079202Novikova 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.
- Results publication: PubMed 26226243Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.
- Results publication: PubMed 26698831Simonazzi G, Bisulli M, Saccone G, Moro E, Marshall A, Berghella V. Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2016 Jan;95(1):28-37. doi: 10.1111/aogs.12798. Epub 2015 Nov 12.
- Results publication: PubMed 27558956Ker K, Shakur H, Roberts I. Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG. 2016 Oct;123(11):1745-52. doi: 10.1111/1471-0528.14267. Epub 2016 Aug 24.
- Results publication: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Results publication: PubMed 28456509WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
- Results publication: PubMed 26118386Bouet PE, Ruiz V, Legendre G, Gillard P, Descamps P, Sentilhes L. Policy of high-dose tranexamic acid for treating postpartum hemorrhage after vaginal delivery. J Matern Fetal Neonatal Med. 2016;29(10):1617-22. doi: 10.3109/14767058.2015.1056731. Epub 2015 Jun 29.
- Results publication: PubMed 26952346Sujata N, Tobin R, Kaur R, Aneja A, Khanna M, Hanjoora VM. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016 Jun;133(3):312-5. doi: 10.1016/j.ijgo.2015.09.032. Epub 2016 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen E Farrell, MD principal investigator
United States Naval Medical Center, San Diego,CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid 1000 mg/10ml normal saline infusion in people with Postpartum Hemorrhage, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postpartum hemorrhage (time frame: Up to six weeks from date of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326596, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.