Pelvic Organ ProlapsePhase 4TEXASNCT06419075
Tranexamic Acid in Vaginal Reconstructive Surgery
A Phase 4 study testing Tranexamic acid, Vasopressin and NaCl 0.9% in people with Pelvic Organ Prolapse, run by The University of Texas Medical Branch, Galveston.
Trial summary
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. Read more about this study
- Who is it for?
- Ages 50 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Tranexamic acid, Vasopressin and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 27 Jan 2025
- 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 50 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females who are menopausal at the time of consent
- Able to understand and read English
- Able and willing to provide written informed consent
- Able to comply with the follow-up study protocol, per clinician judgment
- Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV
- LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures
- History of abdominal or vaginal surgery for POP
- American Society of Anesthesiologists (ASA) physical status I or II
Who cannot join
- Texas Department of Criminal Justice prisoners
- Refusal of blood products (e.g, Jehovah's witnesses)
- ASA physical status III or IV
- Known allergy or hypersensitivity to TXA or any of the ingredients
- Subarachnoid hemorrhage
- Active intravascular clotting, thromboembolic disease (cerebral thrombosis, deep vein thrombosis, or pulmonary embolism)
Show all 16Show fewer
- Epilepsy, seizure disorders requiring anti-epileptic medication(s)
- Acquired impaired color vision (color blindness, retinal involvement)
- Intrinsic risk of thrombosis or thromboembolism (hypercoagulopathy, thrombogenic cardiac rhythm disease, thrombogenic valvular disease)
- History of severe liver disease
- Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol
- History of cardiac diseases (decompensated congestive heart failure CHF, recent coronary artery disease CAD within 30 days, recent myocardial infarction MI within 30 days)
- History of reversible nephrogenic diabetes insipidus
- History of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
- Prior or current pelvic radiation, or chemotherapy.
- Females who desires to have vaginal sexual intercourse after the surgery
About this study
Official title: Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.
Read the detailed description
This is a multicenter, double blinded, pilot randomized clinical trial that will be conducted at UTMB Health, and other participating sites. Each participating site will obtain IRB approval. Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessment will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to the local TXA, or Vasopressin, or NS group with the total sample size of 36 female subjects (12 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. The anesthesia team is responsible for preparing the study agents, monitoring intraoperative cardiovascular parameters (blood pressure and heart rate) as well as adverse events, and determining the blood transfusion if needed. Subsequently, the subject will have postoperative follow up at 2 weeks and 6 weeks
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Tranexamic acid, Vasopressin, NaCl 0.9%
- Keywords
- Tranexamic Acid, Colpocleisis
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Tranexamic acid (CYKLOKAPRON) (Pfizer, New York, NY).
The intervention of 50 cc TXA (2 mg/mL) local infiltration is determined after carefully reviewing the literature. Scarafoni et al. recommends that the local TXA should not exceed at a concentration of 5-10 mg/mL to avoid cytotoxicity that may affect the wound re-epithelialization (22). In a prospective study on facelift bleeding, Kochuba et al. demonstrates that local TXA (1-2 mg/mL) with total 100 mg and 200 mg TXA safely and effectively decreased bleeding, operating room time, and drain output compared with traditional local anesthetic technique (14). Fathimani et all reports the local use of modified tumescent anesthesia solution with low TXA concentration (2 mg/dL) and total average dosage of TXA ranging 120-1000 mg is safe and promising in achieving less ecchymosis, edema, and seroma in common facial cosmetic surgical procedures (31). With a total dosage of 100 mg TXA and a volume of 50 cc injection, the concentration is calculated to be 2 mg/dL.
VasopressinDrug
Also called Vasopressin (Vasostrict) (Par Pharmaceutical, Chestnut Ridge, NY).
The intervention of 50 cc Vasopressin (0.1U/mL) local infiltration is determined from several systematic reviews. Hafidh et al. shows that injection of diluted Vasopressin (3.6 to 10 units) with various concentration during hysterectomy significantly reduces the intraoperative blood loss when compared to placebo, and without increasing the hazard of cardiovascular toxicities. Cui et al. reports similar results, but including other vaginal surgeries. The common preparation for dilute Vasopressin is 0.1 U/mL or 1.0 U/mL from a 1cc vial of 20 U/mL Vasopressin. The advantage of 0.1 U/mL concentration is to avoid a relatively large bolus of concentrated 1.0 U/mL Vasopressin injected intravascularly by accident. A cumulative total dose of 4 to 6 units of Vasopressin administered in a dilute solution is proposed to be an upper limit. Therefore, the cumulative total dose of 5 units Vasopressin from 50 cc (0.1U/mL) is in the safe therapeutic range.
NaCl 0.9%Other
The intervention of 50 cc NaCl 0.9% local infiltration serves a placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline (NaCl 0.9%) | Placebo comparator | Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection Receives: Other: NaCl 0.9% |
| Tranexamic Acid (2 mg/dL) | Experimental | Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection Receives: Drug: Tranexamic acid |
| Vasopressin (0.1 U/dL) | Experimental | Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative quantitative blood loss QBL (mL)
Compare intraoperative QBL during colpocleisis with the local infiltration of Tranexamic acid to the current standard of care, vasopressin or normal saline.
Measured: Intraoperatively
Secondary outcomes (5)
Colpocleisis operative time (min)
Compare the colpocleisis operative time between Tranexamic acid, vasopressin or normal saline groups
Measured: Intraoperatively
Intraoperative blood pressure (mmHg)
Evaluate the effect blood pressures at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa.
Measured: Intraoperatively
Intraoperative hear rate (beats/min)
Evaluate the effect on heart rate at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa.
Measured: Intraoperatively
Postoperative complications
Assess postoperative complications following colpocleisis using the Clavien-Dindo Classification (CDC) categories
Measured: 2 weeks and 6 weeks postoperatively
Rate of transfusion
Quantify the need for blood-product transfusion and the volume administered as a direct result of colpocleisis, either intraoperative or postoperative
Measured: Intraoperatively and 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Why it stopped: closed study due to lack of faculty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled subjects will be randomized into one of the 3 arms including tranexamic acid (2 mg/dL), vasopressin (0.1 U/dL), and normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
- Investigators
- Gokhan Kilic, MD, Principal investigator, University of Texas Medical Branch GalvestonAnn Tran, MD, Principal investigator, Mount Sinai Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419075
- Sponsor's protocol ID
- 23-0273
- Acronym
- TEXAS
- Status last verified
- Jan 2025
- First submitted
- 8 May 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to make individual participant data (IPD) available to other researchers.
Publications
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
PubMed 20966694Cheng W, Bu C, Hong F, Zhong X, Jin C, Yang X, Sun X, Wang J. Perioperative hemorrhagic complications in pelvic floor reconstructive surgery. Int Urogynecol J. 2019 Jul;30(7):1141-1146. doi: 10.1007/s00192-018-3667-6. Epub 2018 May 21.
PubMed 29785542Lambrou NC, Buller JL, Thompson JR, Cundiff GW, Chou B, Montz FJ. Prevalence of perioperative complications among women undergoing reconstructive pelvic surgery. Am J Obstet Gynecol. 2000 Dec;183(6):1355-8; discussion 1359-60. doi: 10.1067/mob.2000.110911.
PubMed 11120496Johnson DJ, Scott AV, Barodka VM, Park S, Wasey JO, Ness PM, Gniadek T, Frank SM. Morbidity and Mortality after High-dose Transfusion. Anesthesiology. 2016 Feb;124(2):387-95. doi: 10.1097/ALN.0000000000000945.
PubMed 26569167Ghadimi K, Levy JH, Welsby IJ. Perioperative management of the bleeding patient. Br J Anaesth. 2016 Dec;117(suppl 3):iii18-iii30. doi: 10.1093/bja/aew358.
PubMed 27940453Cui Y, Chen I, Chernoff A, Clancy A. Effectiveness of prophylactic pharmacological hemostatic agents for reduction of blood loss at vaginal surgery: a systematic review and meta-analysis. Int Urogynecol J. 2023 Dec;34(12):2945-2957. doi: 10.1007/s00192-023-05614-1. Epub 2023 Aug 16.
PubMed 37584705Hafidh B, Latifah HM, Gari A, Alshahrani MS, AlSghan R, Alkhamis WH, Allam HS, AlRasheed MA, Bakhsh H, Abu-Zaid A, Baradwan S. Vasopressin to Control Blood Loss during Hysterectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2022 Mar;29(3):355-364.e2. doi: 10.1016/j.jmig.2021.10.003. Epub 2021 Oct 12.
PubMed 34648933Willis-Gray MG, Husk KE, Brueseke TJ, Connolly A, Geller EJ. Lidocaine Use in Vaginal Surgery and Risk of Toxicity. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):546-549. doi: 10.1097/SPV.0000000000000622.
PubMed 30346319Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6.
PubMed 31865770Luetzenberg FS, Lyford-Pike S. Modern use of tranexamic acid in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg. 2023 Aug 1;31(4):219-223. doi: 10.1097/MOO.0000000000000886. Epub 2023 Apr 13.
PubMed 37052603Breau RH, Kokolo MB, Punjani N, Cagiannos I, Beck A, Niznick N, Buenaventura C, Cowan J, Knoll G, Momoli F, Morash C, Ruzicka M, Schachkina S, Tinmouth A, Xie HY, Fergusson DA. The effects of lysine analogs during pelvic surgery: a systematic review and meta-analysis. Transfus Med Rev. 2014 Jul;28(3):145-55. doi: 10.1016/j.tmrv.2014.05.002. Epub 2014 May 18.
PubMed 24958068El Minawi HM, Kadry HM, El-Essawy NM, El Saadany ZA, Nouh OM. The effect of tranexamic acid on blood loss in liposuction: a randomized controlled study. Eur J Plast Surg. 2023;46(2):227-237. doi: 10.1007/s00238-022-01995-6. Epub 2022 Oct 22.
PubMed 36311870Couto RA, Charafeddine A, Sinclair NR, Nayak LM, Zins JE. Local Infiltration of Tranexamic Acid With Local Anesthetic Reduces Intraoperative Facelift Bleeding: A Preliminary Report. Aesthet Surg J. 2020 May 16;40(6):587-593. doi: 10.1093/asj/sjz232.
PubMed 31504134Kochuba AL, Coombs DM, Kwiecien GJ, Sinclair NR, Zins JE. Prospective Study Assessing the Effect of Local Infiltration of Tranexamic Acid on Facelift Bleeding. Aesthet Surg J. 2021 Mar 12;41(4):391-397. doi: 10.1093/asj/sjaa198.
PubMed 32644111Coombs DM, Kwiecien GJ, Sinclair NR, Jin A, Zins JE. Local Infiltration of Tranexamic Acid During Facelift Improves Operating Room Efficiency: A Matched Patient Study. Aesthet Surg J. 2022 Aug 24;42(9):971-977. doi: 10.1093/asj/sjac067.
PubMed 35350068
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06419075
- Acronym / sponsor ID
- TEXAS / 23-0273
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Tranexamic Acid, Colpocleisis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed study due to lack of faculty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, The University of Texas Health Science Center, Houston
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 17 May 2024 (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.
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.
Detailed description
This is a multicenter, double blinded, pilot randomized clinical trial that will be conducted at UTMB Health, and other participating sites. Each participating site will obtain IRB approval. Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessment will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to the local TXA, or Vasopressin, or NS group with the total sample size of 36 female subjects (12 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. The anesthesia team is responsible for preparing the study agents, monitoring intraoperative cardiovascular parameters (blood pressure and heart rate) as well as adverse events, and determining the blood transfusion if needed. Subsequently, the subject will have postoperative follow up at 2 weeks and 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The enrolled subjects will be randomized into one of the 3 arms including tranexamic acid (2 mg/dL), vasopressin (0.1 U/dL), and normal saline.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline (NaCl 0.9%) | Placebo comparator | Other: NaCl 0.9%Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection |
| Tranexamic Acid (2 mg/dL) | Experimental | Drug: Tranexamic acidLocal infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection |
| Vasopressin (0.1 U/dL) | Experimental | Drug: VasopressinLocal infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females who are menopausal at the time of consent
- Able to understand and read English
- Able and willing to provide written informed consent
- Able to comply with the follow-up study protocol, per clinician judgment
- Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV
Key exclusion criteria (16 listed)
- Texas Department of Criminal Justice prisoners
- Refusal of blood products (e.g, Jehovah's witnesses)
- ASA physical status III or IV
- Known allergy or hypersensitivity to TXA or any of the ingredients
- Subarachnoid hemorrhage
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 acidAlso: Tranexamic acid (CYKLOKAPRON) (Pfizer, New York, NY).The intervention of 50 cc TXA (2 mg/mL) local infiltration is determined after carefully reviewing the literature. Scarafoni et al. recommends that the local TXA should not exceed at a concentration of 5-10 mg/mL to avoid cytotoxicity that may affect the wound re-epithelialization (22). In a prospective study on facelift bleeding, Kochuba et al. demonstrates that local TXA (1-2 mg/mL) with total 100 mg and 200 mg TXA safely and effectively decreased bleeding, operating room time, and drain output compared with traditional local anesthetic technique (14). Fathimani et all reports the local use of modified tumescent anesthesia solution with low TXA concentration (2 mg/dL) and total average dosage of TXA ranging 120-1000 mg is safe and promising in achieving less ecchymosis, edema, and seroma in common facial cosmetic surgical procedures (31). With a total dosage of 100 mg TXA and a volume of 50 cc injection, the concentration is calculated to be 2 mg/dL. | Drug | Tranexamic Acid (2 mg/dL) |
| VasopressinAlso: Vasopressin (Vasostrict) (Par Pharmaceutical, Chestnut Ridge, NY).The intervention of 50 cc Vasopressin (0.1U/mL) local infiltration is determined from several systematic reviews. Hafidh et al. shows that injection of diluted Vasopressin (3.6 to 10 units) with various concentration during hysterectomy significantly reduces the intraoperative blood loss when compared to placebo, and without increasing the hazard of cardiovascular toxicities. Cui et al. reports similar results, but including other vaginal surgeries. The common preparation for dilute Vasopressin is 0.1 U/mL or 1.0 U/mL from a 1cc vial of 20 U/mL Vasopressin. The advantage of 0.1 U/mL concentration is to avoid a relatively large bolus of concentrated 1.0 U/mL Vasopressin injected intravascularly by accident. A cumulative total dose of 4 to 6 units of Vasopressin administered in a dilute solution is proposed to be an upper limit. Therefore, the cumulative total dose of 5 units Vasopressin from 50 cc (0.1U/mL) is in the safe therapeutic range. | Drug | Vasopressin (0.1 U/dL) |
| NaCl 0.9%The intervention of 50 cc NaCl 0.9% local infiltration serves a placebo control. | Other | Normal Saline (NaCl 0.9%) |
Primary outcome
Intraoperative quantitative blood loss QBL (mL)
Time frame: Intraoperatively
Compare intraoperative QBL during colpocleisis with the local infiltration of Tranexamic acid to the current standard of care, vasopressin or normal saline.
5 secondary outcomes
Colpocleisis operative time (min)
Time frame: Intraoperatively
Intraoperative blood pressure (mmHg)
Time frame: Intraoperatively
Intraoperative hear rate (beats/min)
Time frame: Intraoperatively
Postoperative complications
Time frame: 2 weeks and 6 weeks postoperatively
Rate of transfusion
Time frame: Intraoperatively and 2 weeks postoperatively
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 31 Jan 2025.
- Background: PubMed 20966694Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
- Background: PubMed 29785542Cheng W, Bu C, Hong F, Zhong X, Jin C, Yang X, Sun X, Wang J. Perioperative hemorrhagic complications in pelvic floor reconstructive surgery. Int Urogynecol J. 2019 Jul;30(7):1141-1146. doi: 10.1007/s00192-018-3667-6. Epub 2018 May 21.
- Background: PubMed 11120496Lambrou NC, Buller JL, Thompson JR, Cundiff GW, Chou B, Montz FJ. Prevalence of perioperative complications among women undergoing reconstructive pelvic surgery. Am J Obstet Gynecol. 2000 Dec;183(6):1355-8; discussion 1359-60. doi: 10.1067/mob.2000.110911.
- Background: PubMed 26569167Johnson DJ, Scott AV, Barodka VM, Park S, Wasey JO, Ness PM, Gniadek T, Frank SM. Morbidity and Mortality after High-dose Transfusion. Anesthesiology. 2016 Feb;124(2):387-95. doi: 10.1097/ALN.0000000000000945.
- Background: PubMed 27940453Ghadimi K, Levy JH, Welsby IJ. Perioperative management of the bleeding patient. Br J Anaesth. 2016 Dec;117(suppl 3):iii18-iii30. doi: 10.1093/bja/aew358.
- Background: PubMed 37584705Cui Y, Chen I, Chernoff A, Clancy A. Effectiveness of prophylactic pharmacological hemostatic agents for reduction of blood loss at vaginal surgery: a systematic review and meta-analysis. Int Urogynecol J. 2023 Dec;34(12):2945-2957. doi: 10.1007/s00192-023-05614-1. Epub 2023 Aug 16.
- Background: PubMed 34648933Hafidh B, Latifah HM, Gari A, Alshahrani MS, AlSghan R, Alkhamis WH, Allam HS, AlRasheed MA, Bakhsh H, Abu-Zaid A, Baradwan S. Vasopressin to Control Blood Loss during Hysterectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2022 Mar;29(3):355-364.e2. doi: 10.1016/j.jmig.2021.10.003. Epub 2021 Oct 12.
- Background: PubMed 30346319Willis-Gray MG, Husk KE, Brueseke TJ, Connolly A, Geller EJ. Lidocaine Use in Vaginal Surgery and Risk of Toxicity. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):546-549. doi: 10.1097/SPV.0000000000000622.
- Background: PubMed 31865770Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6.
- Background: PubMed 37052603Luetzenberg FS, Lyford-Pike S. Modern use of tranexamic acid in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg. 2023 Aug 1;31(4):219-223. doi: 10.1097/MOO.0000000000000886. Epub 2023 Apr 13.
- Background: PubMed 24958068Breau RH, Kokolo MB, Punjani N, Cagiannos I, Beck A, Niznick N, Buenaventura C, Cowan J, Knoll G, Momoli F, Morash C, Ruzicka M, Schachkina S, Tinmouth A, Xie HY, Fergusson DA. The effects of lysine analogs during pelvic surgery: a systematic review and meta-analysis. Transfus Med Rev. 2014 Jul;28(3):145-55. doi: 10.1016/j.tmrv.2014.05.002. Epub 2014 May 18.
- Background: PubMed 36311870El Minawi HM, Kadry HM, El-Essawy NM, El Saadany ZA, Nouh OM. The effect of tranexamic acid on blood loss in liposuction: a randomized controlled study. Eur J Plast Surg. 2023;46(2):227-237. doi: 10.1007/s00238-022-01995-6. Epub 2022 Oct 22.
- Individual participant dataSharing planned: No. We are not planning to make individual participant data (IPD) available to other researchers.
Related trials for Pelvic Organ Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
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.
Gokhan Kilic, MD principal investigator
University of Texas Medical Branch Galveston
Ann Tran, MD principal investigator
Mount Sinai Hospital & Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid, Vasopressin and NaCl 0.9% in people with Pelvic Organ Prolapse, run by The University of Texas Medical Branch, Galveston.
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 8 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Intraoperative quantitative blood loss QBL (mL) (time frame: Intraoperatively). 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 NCT06419075, which also lists 26 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 31 Jan 2025.