NCT04537533

Brief Summary

Bladder cancer is one of the most common cancers of the genitourinary tract in adults, and its incidence distinctly increases with age . In almost two-thirds of cases, the disease is superficial at presentation and involves the mucosal and sub mucosal layers or the lamina propria of the bladder, whereas ∼20% to 30% of patients have muscle-invasive tumors. Superficial bladder cancer is treated by transurethral endoscopic resection, which can be followed by endovesical therapy for patients at risk of disease recurrence and progression . In contrast, muscle-invasive bladder cancer is generally treated by radical cystectomy with pelvic lymph node dissection and then creation of urinary diversion to create an alternate route for urine passage, which demonstrates 10-year recurrence-free survival rates of 50% to 59% and overall survival rates of ∼45% . These major surgeries have a prolonged operative times and are associated with significant risk of complications including high risk of perioperative bleeding and subsequent need for blood transfusion with significant postoperative complications, which are reportedly in the range of 24% to 64% .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 30, 2020

Last Update Submit

August 30, 2020

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Effect of low dose and high dose tranexemic acid infusion on Intraoperative blood loss .

    Estimated Blood Loss and perioperative need for blood transfusion within the first 15 days .

    within the first 15 days

Secondary Outcomes (1)

  • Postoperative thromboembolic events

    within the first 15 days

Study Arms (3)

first group

EXPERIMENTAL

1st group (A) will include 30 patients: each one will receive 15mg/kg of I.V tranexemic acid as a bolus over 10 minutes (loading dose) then 10mg/kg/hour of I.V tranexemic acid as infusion all through the operation.

Drug: Tranexamic acidOther: Normal saline

second group

ACTIVE COMPARATOR

2nd group (B) will include 30 patients: : each one will receive 5mg/kg of I.V tranexemic acid as a bolus over 10 minutes (loading dose) then 1mg/kg/hour of I.V tranexemic acid as infusion all through the operation.

Drug: Tranexamic acidOther: Normal saline

Third group

PLACEBO COMPARATOR

3rd group (C){controlled group} will include 30 patients: each one will receive saline (placebo) injection and infusion all through the operation.

Other: Normal saline

Interventions

Tranexamic acidDRUG

Intraoperative infusion

first groupsecond group
Normal salineOTHER

intravenous infusion

Third groupfirst groupsecond group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 - 70 years old
  • Gender: Males and females
  • ASA grade I - II
  • Patients undergoing radical cystectomy for bladder cancer regardless of tumor stage and histology.
  • Patients who have undergone previous surgery, radiation, or chemotherapy may be included.
  • All forms of urinary diversion are allowed

You may not qualify if:

  • Patient refusal.
  • Patient with allergy to tranexamic acid.
  • Patients have thromboembolic disease (active or diagnosed within 1 year), such as deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral thrombosis or MI.
  • Pregnancy.
  • Patients with hematuria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.

    PMID: 19576682BACKGROUND

  • Parkin DM. The global burden of urinary bladder cancer. Scand J Urol Nephrol Suppl. 2008 Sep;(218):12-20. doi: 10.1080/03008880802285032.

    PMID: 19054893BACKGROUND

  • Thompson E. Urological oncology in Europe. Research highlights from the XVIIth congress of the European Association of Urology, Birmingham, UK, February 23-26, 2002. Drugs Today (Barc). 2002 Apr;38(4):221-34. No abstract available.

    PMID: 12532191BACKGROUND

  • Meyer JP, Blick C, Arumainayagam N, Hurley K, Gillatt D, Persad R, Fawcett D. A three-centre experience of orthotopic neobladder reconstruction after radical cystectomy: revisiting the initial experience, and results in 104 patients. BJU Int. 2009 Mar;103(5):680-3. doi: 10.1111/j.1464-410X.2008.08204.x. Epub 2008 Dec 2.

    PMID: 19076133BACKGROUND

  • Cookson MS, Chang SS, Wells N, Parekh DJ, Smith JA Jr. Complications of radical cystectomy for nonmuscle invasive disease: comparison with muscle invasive disease. J Urol. 2003 Jan;169(1):101-4. doi: 10.1016/S0022-5347(05)64045-1.

    PMID: 12478113BACKGROUND

  • Lawrentschuk N, Colombo R, Hakenberg OW, Lerner SP, Mansson W, Sagalowsky A, Wirth MP. Prevention and management of complications following radical cystectomy for bladder cancer. Eur Urol. 2010 Jun;57(6):983-1001. doi: 10.1016/j.eururo.2010.02.024. Epub 2010 Feb 26.

    PMID: 20227172BACKGROUND

  • Lowrance WT, Rumohr JA, Chang SS, Clark PE, Smith JA Jr, Cookson MS. Contemporary open radical cystectomy: analysis of perioperative outcomes. J Urol. 2008 Apr;179(4):1313-8; discussion 1318. doi: 10.1016/j.juro.2007.11.084. Epub 2008 Mar 4.

    PMID: 18289578BACKGROUND

  • Chang SS, Smith JA Jr, Wells N, Peterson M, Kovach B, Cookson MS. Estimated blood loss and transfusion requirements of radical cystectomy. J Urol. 2001 Dec;166(6):2151-4.

    PMID: 11696725BACKGROUND

  • Shabsigh A, Korets R, Vora KC, Brooks CM, Cronin AM, Savage C, Raj G, Bochner BH, Dalbagni G, Herr HW, Donat SM. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol. 2009 Jan;55(1):164-74. doi: 10.1016/j.eururo.2008.07.031. Epub 2008 Jul 18.

    PMID: 18675501BACKGROUND

  • Novara G, De Marco V, Aragona M, Boscolo-Berto R, Cavalleri S, Artibani W, Ficarra V. Complications and mortality after radical cystectomy for bladder transitional cell cancer. J Urol. 2009 Sep;182(3):914-21. doi: 10.1016/j.juro.2009.05.032. Epub 2009 Jul 17.

    PMID: 19616246BACKGROUND

  • Hautmann RE, de Petriconi RC, Volkmer BG. Lessons learned from 1,000 neobladders: the 90-day complication rate. J Urol. 2010 Sep;184(3):990-4; quiz 1235. doi: 10.1016/j.juro.2010.05.037.

    PMID: 20643429BACKGROUND

  • Quek ML, Stein JP, Daneshmand S, Miranda G, Thangathurai D, Roffey P, Skinner EC, Lieskovsky G, Skinner DG. A critical analysis of perioperative mortality from radical cystectomy. J Urol. 2006 Mar;175(3 Pt 1):886-9; discussion 889-90. doi: 10.1016/S0022-5347(05)00421-0.

    PMID: 16469572BACKGROUND

  • Clement C, Rossi P, Aissi K, Barthelemy P, Guibert N, Auquier P, Ragni E, Rossi D, Frances Y, Bastide C. Incidence, risk profile and morphological pattern of lower extremity venous thromboembolism after urological cancer surgery. J Urol. 2011 Dec;186(6):2293-7. doi: 10.1016/j.juro.2011.07.074. Epub 2011 Oct 20.

    PMID: 22014814BACKGROUND

  • Nilsson IM. Clinical pharmacology of aminocaproic and tranexamic acids. J Clin Pathol Suppl (R Coll Pathol). 1980;14:41-7. No abstract available.

    PMID: 7000846BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Mohamed Reda Abdelaziz, Professor

CONTACT

01003919165mohamed.hassan19@med.au.edu.eg

Ahmed Mokhtar Fathy, Lecturer

CONTACT

01063317380ahmedmokhtar_80@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 3, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

September 3, 2020

Record last verified: 2020-08