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Prophylactic Fibrinogen and perioperative bleeding

Prophylactic Fibrinogen effect on perioperative bleeding in radical cystectomy: a double-blind randomized placebo-controlled study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191013045091N1
Enrollment
35
Registered
2020-01-30
Start date
2019-12-15
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a genitourinary system procedure. Condition 2: Acquired absence of other parts of urinary tract. Condition 3: Malignant neoplasm of bladder, unspecified. Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a genitourinary system procedure Acquired absence of other parts of urinary tract Malignant neoplasm of bladder, unspecified

Interventions

Intervention 1: Intervention group: receive 2 grams of fibrinogen in 100 cc distilled water. Intervention 2: Control group: receive 100 cc normal saline.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years old Admitted for elective radical cystectomy localized bladder cancer (T1–2N0M0)

Exclusion criteria

Exclusion criteria: Anticoagulant agent Having a known blood Abnormality or coagulopathy (abnormal values of platelet count, PT, APTT, fibrinogen, antithrombin, or Ddimer) A history of thromboembolism Chronic liver disease Chronic kidney disease with a serum creatinine level of > 2 mg/dl A preoperative plasma fibrinogen level of = 400 mg/dl intake of non-steroidal anti-inflammatory drugs within 2 days prior to surgery

Design outcomes

Primary

MeasureTime frame
Blood loss during surgery. Timepoint: at the end of surgery. Method of measurement: visual evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Arian nik

Shahid Beheshti University of Medical Sciences

m.ariannik@sbmu.ac.ir+98 21 4447 7493

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 22, 2026