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CompletedNCT03856164TXAUpdated Jan 19, 2021Results posted

Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery

A Phase 2/3 interventional study of Tranexamic Acid and Placebo in Post Partum Hemorrhage, Fibrinolysis; Hemorrhage and Blood Loss, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by University of Texas Southwestern Medical Center · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.

Read the detailed description

Obstetric hemorrhage has been identified as a contributory cause for the United States' suboptimal and inequitable outcomes among pregnant women. As such, obstetric hemorrhage has become a formal focus point in a national agenda to improve maternal outcomes. Strategies to identify maternal hypovolemia and treating obstetric hemorrhage are undergoing organized scrutiny in many states including Texas. Tranexamic acid (TXA) treatment is receiving increased emphasis in obstetric care because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prophylaxis) as well as mitigating ongoing hemorrhage. TXA therapy has been principally studied in nonpregnant populations; results of studies in pregnant women have been lacking.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in a variety of circumstances primarily involving trauma patients. Shakur and co-authors in a trial of 20,000 non-pregnant trauma patients reported a significant reduction in all-cause mortality after TXA administration. In another large study (WOMAN Trial), 20,000 pregnant women with hemorrhage were randomized to TXA or placebo. TXA was associated with a significant decrease in death due to bleeding.

Tranexamic acid's role in treating hemorrhage have been widely studied in non-pregnant populations. Studies of TXA in obstetrics are limited. The American College of Obstetricians and Gynecologists believes the data is insufficient to recommend tranexamic acid for prophylaxis.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing prior to incision for cesarean delivery with a repeat dose given at placental delivery. The purpose is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The investigators elected to study scheduled elective cesareans because such procedures are at low risk for profound hemorrhage. It is the intent to have a study cohort where the two treatment groups (TXA or placebo) are as comparable as possible, so the efficacy of TXA is not tested in women with highly variable volumes of obstetric hemorrhage.

02

Conditions studied

  • Post Partum Hemorrhage
  • Fibrinolysis; Hemorrhage
  • Blood Loss

Keywords

  • Tranexamic acid
  • TXA
  • Anti-fibrinolytics
  • Postpartum hemorrhage
  • Obstetric hemorrhage
  • Fibrinolysis
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 110 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Intrauterine pregnancy
  2. Age ≥ 18
  3. Gestation age ≥ 37 weeks 0 days
  4. Scheduled cesarean delivery
  5. Second or third cesarean delivery
  6. Singleton pregnancy

Exclusion criteria

Exclusion Criteria:

  1. First cesarean delivery
  2. Four or more cesarean deliveries
  3. Intrauterine fetal death
  4. Fetal anomalies
  5. Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
  6. Thrombocytopenia (Platelet count \< 100k)
  7. Internal bleeding, external bleeding, easy bruising
  8. History of thrombotic event
  9. Hypertension
  10. Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)
  11. Insulin-treated diabetes
  12. Suspected morbidly adherent placenta
  13. Placenta previa
  14. Multiple Gestations
  15. BMI ≥ 50
  16. Hematocrit ≤ 25
  17. Blood transfusion within 24 hours prior to cesarean delivery
  18. History of abnormal bleeding or blood disorder
  19. Planned general anesthesia
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Active comparator
    Tranexamic acid

    Tranexamic Acid for intravenous administration.

    Drug: Tranexamic Acid

  • Placebo comparator
    Placebo

    Normal saline for intravenous administration.

    Drug: Placebo

Interventions

  • DrugTranexamic Acid

    Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.

    Also known as: Cyklokapron

  • DrugPlacebo

    100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.

    Also known as: Normal Saline

06

What researchers measure

Primary outcomes

  1. Blood Volume Loss

    Total blood volume loss will be calculated in milliliters.

    Time frame: 24 hours postpartum.

Secondary outcomes

  1. D-Dimer (µg/mL)

    Measured from blood sample collection.

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  2. Fibrinogen (mg/dL)

    Measured from blood sample collection.

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  3. Tissue Plasminogen Activator Antigen (ng/mL)

    Measured from blood sample collection.

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  4. Plasminogen Activator Inhibitor-Type-1 (Units/mL)

    Measured from blood sample collection.

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  5. Rotational Thromboelastometry INTEM and EXTEM Clotting Time

    Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

  6. Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness

    Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).

    Time frame: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

07

Results

Posted Jan 19, 2021

Participant flow

Participants were recruited based on admission for delivery at an academic center between June 2019 and January 2020. The first participant was enrolled on June 17, 2019, and the last participant was enrolled on January 10, 2020.

Participant flow — Overall Study
MilestoneTranexamic AcidPlacebo
Started5555
Completed5555
Not completed00

Outcome measures

PrimaryBlood Volume Loss

Total blood volume loss will be calculated in milliliters.

Time frame:
24 hours postpartum.
Reported as:
Mean · milliliters
Blood Volume Loss
millilitersTranexamic AcidPlacebo
Blood Volume Loss2274 ± 4692407 ± 388
SecondaryD-Dimer (µg/mL)

Measured from blood sample collection.

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · µg/mL
D-Dimer (µg/mL)
µg/mLTranexamic AcidPlacebo
Before Surgery2.9 ± 1.54.0 ± 5.3
After Delivery2.4 ± 1.33.8 ± 4.7
P.O.D. 12.1 ± 1.24.3 ± 2.4
SecondaryFibrinogen (mg/dL)

Measured from blood sample collection.

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · mg/dL
Fibrinogen (mg/dL)
mg/dLTranexamic AcidPlacebo
Before Surgery563.5 ± 83.9550.7 ± 68.2
After Delivery499.6 ± 77484.9 ± 82.5
P.O.D. 1527.4 ± 69.8525.4 ± 86.1
SecondaryTissue Plasminogen Activator Antigen (ng/mL)

Measured from blood sample collection.

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · ng/mL
Tissue Plasminogen Activator Antigen (ng/mL)
ng/mLTranexamic AcidPlacebo
Before Surgery8.1 ± 3.68.2 ± 2.7
After Delivery9.0 ± 3.79.6 ± 2.9
P.O.D. 17.5 ± 3.77.4 ± 3.3
SecondaryPlasminogen Activator Inhibitor-Type-1 (Units/mL)

Measured from blood sample collection.

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · IU/mL
Plasminogen Activator Inhibitor-Type-1 (Units/mL)
IU/mLTranexamic AcidPlacebo
Before Surgery81.8 ± 34.761.7 ± 33.8
After Delivery67.0 ± 32.363.3 ± 31.9
P.O.D. 120.7 ± 26.722.1 ± 28.5
SecondaryRotational Thromboelastometry INTEM and EXTEM Clotting Time

Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · seconds
Rotational Thromboelastometry INTEM and EXTEM Clotting Time
secondsTranexamic AcidPlacebo
Before Surgery INTEM Clotting Time149.7 ± 14.4150.5 ± 14.2
After Delivery INTEM Clotting Time137.4 ± 18.3140.7 ± 29.9
P.O.D. 1 INTEM Clotting Time145.1 ± 16.3141.2 ± 16.4
Before Surgery EXTEM Clotting Time54.0 ± 5.156.1 ± 7.2
After Delivery EXTEM Clotting Time54.9 ± 6.356.3 ± 8.0
P.O.D. 1 EXTEM Clotting Time49.3 ± 5.350.2 ± 6.9
SecondaryRotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness

Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter).

Time frame:
Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.
Reported as:
Mean · millimeter
Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness
millimeterTranexamic AcidPlacebo
Before Surgery INTEM Maximum Clot Firmness69.3 ± 3.369.4 ± 3.7
After Delivery INTEM Maximum Clot Firmness68.9 ± 3.268.4 ± 5.5
P.O.D. 1 INTEM Maximum Clot Firmness68.8 ± 3.168.8 ± 3.8
Before Surgery EXTEM Maximum Clot Firmness70.8 ± 3.171.2 ± 3.5
After Delivery EXTEM Maximum Clot Firmness69.8 ± 3.169.6 ± 5.5
P.O.D. 1 EXTEM Maximum Clot Firmness70.5 ± 2.870.4 ± 4.0
Before Surgery FIBTEM Maximum Clot Firmness24.2 ± 3.823.9 ± 4.8
After Delivery FIBTEM Maximum Clot Firmness22.5 ± 4.122.0 ± 4.4
P.O.D. 1 FIBTEM Maximum Clot Firmness25.8 ± 4.725.0 ± 5.0

Adverse events

Collected over During patient admission, minimum of 3 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tranexamic Acid0/55 (0%)0/55 (0%)—
Placebo0/55 (0%)0/55 (0%)—

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tranexamic AcidPlaceboTotal
Mean29.8 ± 5.228.7 ± 5.229.3 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)Tranexamic AcidPlaceboTotal
Female5555110
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tranexamic AcidPlaceboTotal
Black, non-Hispanic1910
White, non-Hispanic202
Hispanic524698
Region of Enrollment
Region of Enrollment(participants)Tranexamic AcidPlaceboTotal
United States5555110
Parity
Parity(Participants)Tranexamic AcidPlaceboTotal
Parity = 1262349
Parity = 2262753
Parity = 3134
Parity = 4123
Parity = 5101
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2)(Participants)Tranexamic AcidPlaceboTotal
< 25134
25 - < 30171633
30 - < 35171633
35 - < 40101323
> =4010717
08

Study locations

1 site
  • Parkland Hospital
    Dallas, Texas 75235, United States
09

References and documents

Publications

  • American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available. PubMed 25545654 ↗
  • WHO 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 23586122 ↗
  • Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25. PubMed 18819848 ↗
  • GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. doi: 10.1016/S0140-6736(16)32609-5. PubMed 27733286 ↗
  • WOMAN 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. Erratum In: Lancet. 2017 May 27;389(10084):2104. doi: 10.1016/S0140-6736(17)31220-5. PubMed 28456509 ↗
  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. PubMed 28937571 ↗
  • Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6. PubMed 29490690 ↗
  • Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017. PubMed 10400410 ↗
  • Hernandez JS, Alexander JM, Sarode R, McIntire DD, Leveno KJ. Calculated blood loss in severe obstetric hemorrhage and its relation to body mass index. Am J Perinatol. 2012 Aug;29(7):557-60. doi: 10.1055/s-0032-1310528. Epub 2012 Apr 11. PubMed 22495893 ↗
  • Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12. PubMed 19459866 ↗
  • Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. PubMed 16581405 ↗
  • Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869. Erratum In: Obstet Gynecol. 2015 Nov;126(5):1111. Obstet Gynecol. 2019 Jun;133(6):1288. doi: 10.1097/AOG.0000000000003292. PubMed 26241269 ↗
  • McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000. PubMed 22397329 ↗
  • Molina RL, Pace LE. A Renewed Focus on Maternal Health in the United States. N Engl J Med. 2017 Nov 2;377(18):1705-1707. doi: 10.1056/NEJMp1709473. No abstract available. PubMed 29091560 ↗
  • 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 25103301 ↗
  • John M. Eisenberg Center for Clinical Decisions and Communications Science. Management of Postpartum Hemorrhage: Current State of the Evidence. 2016 Jul 12. In: Comparative Effectiveness Review Summary Guides for Clinicians [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007-. Available from http://www.ncbi.nlm.nih.gov/books/NBK379234/ PubMed 27512800 ↗
  • Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942. PubMed 30134136 ↗
  • Ogunkua OT, Duryea EL, Nelson DB, Eddins MM, Klucsarits SE, McIntire DD, Leveno KJ. Tranexamic acid for prevention of hemorrhage in elective repeat cesarean delivery-a randomized study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100573. doi: 10.1016/j.ajogmf.2022.100573. Epub 2022 Jan 15. PubMed 35038612 ↗

Study documents

  • Study protocol · Feb 13, 2019
  • Statistical analysis plan · Feb 13, 2019
  • Informed consent form · Feb 13, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03856164
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Olutoyosi Ogunkua, MD (Assistant Professor of Anesthesiology, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Feb 27, 2019
Start date
Jun 17, 2019
Primary completion
Jan 10, 2020
Completion
Aug 31, 2020
Results posted
Jan 19, 2021
Last update
Jan 19, 2021

Study contacts

Olutoyosi Ogunkua, M.D.
principal investigator · UT Southwestern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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