NCT02653261

Brief Summary

Transurethral resection of the prostate (TURP) represents the gold standard in the operative management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most important complications of urological endoscopic resections is intraoperative and postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury, fluid overload, increased costs and hospital length of stay. Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery and orthopedic surgical procedures but few studies have assessed the efficacy of this antifibrinolytic agent in urological endoscopic procedures. The investigators designed this double-blind, placebo controlled study evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in patients undergoing endoscopic surgery in urology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

January 3, 2016

Last Update Submit

October 9, 2016

Conditions

Hemorrhage

Keywords

tranexamic acidTransurethral Resection of the Prostate (TURP)Transurethral Resection of a Bladder Tumor (TURBT)HemorrhageBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Number of red blood cell transfusions

    From surgery until 72 hours postoperatively

Secondary Outcomes (5)

  • The difference in preoperative and postoperative hematocrit levels to estimate blood loss.

    the first postoperative day

  • Episodes of acute urinary retention

    the first postoperative day

  • Postoperative bleeding with clot retention

    the first postoperative day

  • Episodes of bladder tamponade requiring evacuation or reintervention

    the first postoperative day

  • Postoperative myocardial ischemia assessed by cardiac troponin I

    the first postoperative day

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Tranexamic Acid (TXA): bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

An equal volume of saline

Drug: Placebo

Interventions

Tranexamic AcidDRUG

Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Also known as: Exacyl
Tranexamic Acid
PlaceboDRUG

An equal volume of saline

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>/=18)
  • male or female
  • Undergoing elective TURP or TURBT
  • Spinal anesthesia
  • Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

You may not qualify if:

  • Atrial fibrillation
  • Coronary artery disease treated with drug eluting stent
  • Severe chronic renal failure
  • Congenital or acquired thrombophilia
  • Known or suspected allergy to tranexamic acid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ali JENDOUBI

    University Tunis El Manar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 12, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)