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Randomized clinical trial comparing the effect of different homeostatic agents for controlling homeostasis after hepatic resection.

Randomized clinical trial comparing the effect of Surgicel, TachoSil and Glubran 2 in controlling bleeding after liver resection

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013031712834N1
Enrollment
45
Registered
2013-05-01
Start date
2013-02-19
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Liver metastasis. Condition 2: Malignant neoplasm of liver and intrahepatic bile ducts. Condition 3: Topical homeostatic agents. Condition 4: Other diseases of liver in need of surgery. Secondary malignant neoplasm of liver and intrahepatic bile duct Malignant neoplasm of liver and intrahepatic bile ducts Topical agent, unspecified Other specified diseases of liver

Interventions

Intervention 1: In Surgicel group, Surgicel (a topical cellulose homeostatic agent) in the size of 10*20 cm will be used to control bleeding. Intervention 2: In TachoSil group, TachoSil (contains hum
Treatment - Drugs
In Surgicel group, Surgicel (a topical cellulose homeostatic agent) in the size of 10*20 cm will be used to control bleeding
In TachoSil group, TachoSil (contains human coagulation factor components: fibrinogen and thrombin) in the size of 4.8*4.8 cm will be used to control bleeding
In Glubran2 group, one Glubran2 glue (N-butyl -2-cyanoacrylate) will bee used to control bleeding.

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age between 18-75 years old; all patients undergoing hepatic resection and have oozing after resection; patients with no coagulation disorders Exclusion criteria: Death during the surgery;hepatic mass to be none resectable; early closure of the surgery; hepatic insufficiency after surgery; coagulopathy after the surgery; patients with need for re-surgery due to bleeding or bile leakage other than resection site; patients with chronic hepatic disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bleeding control. Timepoint: Every 6 hours until 48 hours. Method of measurement: Observation during surgery and evaluation of Hb, INR every 6 hours.

Secondary

MeasureTime frame
Complications after oozing control. Timepoint: Days 1, 3, 5,7 after surgery. Method of measurement: Physical examination and paraclinical evaluations.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mir Salim Seayed Sadeghi

Tabriz University of Medical Sciences

seayedsadeghim@tbzmed.ac.ir+98 41 1334 1317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026