Comparing the perioperative blood loss in hypovolemic phlebotomy vs non-hypovolemic phlebotomy with low central venous pressure in patients undergoing open liver resection, A Prospective Randomized Double-Blind Controlled Study

Phase 2

• Conditions: The role of hypovolemic phlebotomy to maintained low CVP and minimized blood loss and blood transfusion during open liver resection.; Low CVP, Hypovolemic phlebotomy, Hepatectomy, Intraoperative blood loss, Blood transfusion

• Registration Number: TCTR20201203005
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-03
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. All genders, age 18 to 70 years old
2. American Society of Anesthesiologists (ASA) physical status classification of I-III
3. The patients who scheduled in elective open liver resection and diagnosed Hepatocellular Carcinoma, Cholangiocarcinoma, Liver metastasis, and Benign malignant tumor.

Exclusion Criteria

1. Pregnancy
2. Refusal of blood and blood products transfusion
3. Anemia (Hb <10 g/dL)
4. Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, active coronary artery disease within 6 months prior surgery)
5. History of significant cerebrovascular disease (Patients with clinically significant stroke/CVA within 6 months prior surgery, severe carotid stenosis)
6. History of significant peripheral vascular disease (Patients with regular claudication)
7. History of congestive heart failure (CHF)
8. Restrictive or obstructive pulmonary disease (COPD)
9. Renal dysfunction (creatinine > 1.8 mg/dL)
10. Abnormal coagulation parameters (INR >1.5 not on warfarin and/or platelet count <100,000)
11. Evidence of hepatic metabolic disorder (bilirubin >2 mg/dL or ALT >75 U/L)
12. Preoperative autologous blood donation
13. Presence of active infection (Evidence of positive hemoculture)
14. Tumor size > 10 cm.
Withdrawal criteria:
1. Unresectable tumor
2. Persistent intraoperative hypotension that cannot be corrected with vasopressors.
3. Cardiac arrest during operation
4. Low central venous pressure (< 5 mmHg) cannot be achieved before and during parenchymal resection.
5. Massive bleeding due to major vascular injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified