Efficay of fibrinogen in liver transplantatio

Phase 1

• Conditions: iver transplantation is a special risk situation for acute and severe bleeding determined by the complexity of the surgical procedure and by the alteration of haemostasis and coagulation factors, especially fibrinogen, present in the patient affected by a terminal hepatopathy.; MedDRA version: 20.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002510-13-ES
• Lead Sponsor: Antoni Sabaté Pes (Servicio de Anestesiología y Reanimación) del Hospital Universitari de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

- Adult men and women (=18 years old)
- Being a candidate for an orthotopic liver transplant
- To have granted the Informed Consent to participate in the study
- Final inclusion criteria: Preoperative hemoglobin Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Clinical exclusion criteria: preoperative hemoglobin> 130 g/L or any of the following clinical situations:

- Familial amyloid polyneuropathy
- Hepatic Polycystosis
- Live donor receptor
- Receiver of donor in asystole, Maastricht type 2
- Acute / subacute liver failure
- Retransplantation in acute phase (first transplant in the same hospitalization)
- Pregnancy and lactation.
- Age less than 18 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified