Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

The First Affiliated Hospital with Nanjing Medical University100 enrolled

Overview

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are: 1. The safety and feasibility of HP 2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Hepatocellular Carcinoma * Preference for laparoscopic hepatectomy and patient agreement Exclusion Criteria: * Age \<18 years * Pregnancy * Refusal of blood product transfusion * Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) * History of significant cerebrovascular disease * Restrictive or obstructive pulmonary disease * Uncontrolled hypertension * Renal dysfunction (glomerular filtration rate \<60 mL/min), * Hemoglobin \<100 g/L * Abnormal coagulation values (international normalized ratio \>1.5 not on warfarin and/or platelet count \<100 ×109/L) * Evidence of hepatic metabolic disorder (bilirubin \>35 mmol/L) * Presence of active infection * Preoperative autologous blood donation * Patients were not allowed to receive erythropoietin at any time during the index hospitalization.

Outcomes

Primary Outcomes

The proportion of allogeneic red blood cell products transfusion

The primary end point of the study was the proportion of patients who required transfusion of allogeneic red blood cell products during laparoscopic hepatectomy or at any time during the hospitalization during the index admission.

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcomes

The volume of Phlebotomy

Time frame: From the start of operation until the end of operation.

The volume of Intraoperative blood loss

Time frame: From the start of operation until the end of operation (during the operation).

The volume of Allogeneic transfusion (perioperative)

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

The volume of Allogeneic transfusion (postoperative)

Time frame: From the end of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

The volume of Allogeneic transfusion (intraoperative)

Time frame: From the start of operation until the end of operation.

The volume of Fresh frozen plasm (FFP) transfusion

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

The volume of Platelets transfusion

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

The volume of Albumin transfusion

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

Perioperative lowest concentration of Hb

Time frame: From the start of operation until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months.

Pre-transection central venous pressure (CVP), (basic CVP)

Time frame: From the start of anesthesia induction until the star of operation.

Lowest central venous pressure (CVP)

Time frame: From the start of operation until the end of operation (during the operation).

time of pringle maneuver

Time frame: From the start of operation until the end of operation.

number of pringle maneuver

how many patients have the pringle maneuver

Time frame: From the start of operation until the end of operation.

operating time

Time frame: From the start of operation until the end of operation.

The proportion of laparoscopic hepatectomy converted to open liver resection

Time frame: From the start of operation until the end of operation.

Length of stay

Time frame: From date of hospitalization until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months

Number of Participants with postoperative complications (overall)

Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 months.

Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts