Trials Sponsors Conditions Drugs Pricing

Conditions

Erythrocyte Transfusion Liver Transplantation

Outcome Measures

Primary Outcomes (1)

Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.
Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.
within surgical LT procedure

Secondary Outcomes (2)

Blood product need in enrolled patients, in terms of rate of LT patients receiving no additional blood product in comparison with a control-matched series of LT patients accrued in previous observational protocol.
within surgical LT procedure
Rate of graft failure in the prospective sample, as compared to controls.
3 months

Study Arms (1)

Liver transplant recipients receiving blood donors' transfusion

EXPERIMENTAL

Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients.

Biological: Red Blood Cell concentrates from organ donor

Interventions

Red Blood Cell concentrates from organ donorBiological

Intervention is a 3-step procedure consisting of 1) recovering blood from the donor during organ procurement; 2) processing donor blood to RBC units; 3) transfusing donor blood to recipients, if necessary during surgery. 1. Donor blood recovery. A: Donor evaluation. During the donor workup, the donor coordinator team gathers additional information from the donor relatives. If no contraindication to blood collection exists, the donor-recipient ABO-crossmatch is performed, and if negative the donor is considered eligible. B: Donor blood collection. It is carried out by a trained investigator, through the continuous autotransfusion system CATSmart (Fresenius Kabi) in the surgery room. 2. Donor blood processing, carried out using the continuous flow CATSmart device. About 4 RBC units are collected. 3. Donor RBC unit transfusion to recipients according to procedures usually adopted at our hospital (final hb level 8-9 g/dL).

Liver transplant recipients receiving blood donors' transfusion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All adult patients (≥ 18 years) receiving a liver transplant from deceased donors at Fondazione Policlinico A. Gemelli IRCCS are eligible for the study.
Liver procurement at Fondazione Policlinico A. Gemelli IRCCS.

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Study Officials

Luciana Teofili
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 28, 2023

Study Start

June 1, 2023

Actual (reported)

Blood Salvage From Liver Donors: a Feasibility Pilot Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Liver transplant recipients receiving blood donors' transfusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Liver transplant recipients receiving blood donors' transfusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations