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Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

N

Nanjing Medical University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: hypovolemic phlebotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05887661
2022-SR-102

Details and patient eligibility

About

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 Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous.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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

hypovolemic phlebotomy (HP)
Experimental group
Description:
patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP)
Treatment:
Procedure: hypovolemic phlebotomy
Control
No Intervention group
Description:
patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP)

Trial contacts and locations

1

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Central trial contact

Shijiang Liu, MD; Yue Wang

Data sourced from clinicaltrials.gov

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