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Trial Title:
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy
NCT ID:
NCT05887661
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
hypovolemic phlebotomy
low central venous pressure
goal-directed
laparoscopic hepatectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
hypovolemic phlebotomy
Description:
hypovolemic phlebotomy was performed after induction of anesthesia and before the star of
parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.
Arm group label:
hypovolemic phlebotomy (HP)
Other name:
HP
Summary:
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withdrawn approximately 30 min prior to the initiation of liver parenchymal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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Shijiang Liu
Phone:
+86-25-68303569
Email:
liushijiang@jsph.org.cn
Start date:
May 1, 2022
Completion date:
May 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887661
