Clinical Trials Logo
  1. Home
  2. Intraoperative Bleeding
  3. NCT01539057

The Efficacy of the Administration of Fibrinogen in Liver Transplantation — FibstudLT  

Intraoperative Bleeding Clinical Trial

Official title:
A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation

Clinical Trial Summary

Objective:

- To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.

- To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.

- To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.

Clinical Trial Description

Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:

Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.

Placebo group, to whom the same dose volume of saline will be administered.

Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01539057
Study type Interventional
Source Hospital Universitari de Bellvitge
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 2012
Completion date January 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05900037 - GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery N/A
Recruiting NCT04609410 - Bleeding in Laparoscopic Liver Surgery N/A
Terminated NCT01458561 - Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery Phase 3
Completed NCT01656759 - Use of a Novel Fibrin Sealant in Total Knee Arthroplasty Phase 2/Phase 3
Completed NCT01651806 - Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty Phase 2/Phase 3
Completed NCT05867342 - Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery Phase 4
Not yet recruiting NCT05841251 - Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation N/A
Not yet recruiting NCT06450834 - Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE
Not yet recruiting NCT06427707 - The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries. Phase 2/Phase 3
Completed NCT03820206 - The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women N/A
Completed NCT01891461 - Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR Phase 4
Completed NCT03047070 - Lidocaine in ERAS for FESS Phase 2
Completed NCT04188184 - Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy N/A
Recruiting NCT04697498 - Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations N/A
Completed NCT05385952 - GATT-Patch Versus TachoSil in Liver Surgery N/A
Completed NCT02229292 - Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid Phase 4
Not yet recruiting NCT06264596 - Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery Phase 3
Recruiting NCT03112135 - Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery Phase 2
Recruiting NCT06399445 - Measurement of Blood Loss in Adenotonsillectomy During General Anesthesia According to the Application of Nondepolarizing Muscle Relaxants Phase 4