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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201203005
Enrollment
100
Registered
2020-12-03
Start date
2020-12-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The role of hypovolemic phlebotomy to maintained low CVP and minimized blood loss and blood transfusion during open liver resection. Hypovolemic phlebotomy&#44

Interventions

Hypovolemic phlebotomy: . The whole blood will be collected 7&#45
10 ml/kg of patient body weight to achieve low CVP (CVP < 5 mmHg) without intravenous fluid replacement. Whole blood collecting bags were provided by the blood bank&#44
containing citrate&#45
phosphate&#45
dextrose&#45
adenine solution. ,Non&#45
hypovolemic phlebotomy: Anesthesiologist will be performed the methods to achieve low CVP (CVP < 5 mmHg) by adopting Reverse Trendelenburg’s position (head&#45
up tilt 10°)&#44
intraoperative volume restriction (2 – 4 ml/kg/hr) and intravenously nitroglycerine administration (0.5&#45
3 mcg/kg/minute) before parenchymal resection 30 minutes.
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Hypovolemic Phlebotomy,Non&#45

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All genders&#44; age 18 to 70 years old 2. American Society of Anesthesiologists (ASA) physical status classification of I&#45;III 3. The patients who scheduled in elective open liver resection and diagnosed Hepatocellular Carcinoma&#44; Cholangiocarcinoma&#44; Liver metastasis&#44; and Benign malignant tumor.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Refusal of blood and blood products transfusion 3. Anemia (Hb 1.8 mg/dL) 10. Abnormal coagulation parameters (INR >1.5 not on warfarin and/or platelet count 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

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss Intraoperative period the measured volume of suctioned blood&#44; gauze and swab

Secondary

MeasureTime frame
Intraoperative transfusion Perioperative periods&#45; 30 days postoperatively Observation,Intraoperative blood transfusion Intraoperative period Observation ,Surgical field bleeding Intraoperative period using the bleeding score of the hepatic surgical field,Postoperative major complications Postoperative period Clavien&#45;Dindo classification,Postoperative major complications Postoperative period Clavien&#45;Dindo classification,Postoperative Acute kidney injury Postoperative period Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines,Reoperation Postoperative period observation ,Length of ICU and hospital stay Postoperative period Observation ,Length of ICU and hospital stay Postoperative period Observation ,Length of ICU and hospital stay Postoperative period Observation ,Length of ICU and hospital stay Postoperative period Observation ,Hospital mortality Postoperative period Observation ,Hospital mortality Postoperative period Observation ,Hospital mortality Postoperative period Observation ,30&#45;day readmission 30&#45;day postoperatively Observation ,30&#45;day readmission 30&#45;day postoperatively Observation ,30&#45;day readmission 30&#45;day postoperatively Observation ,Postoperative 30 days mortality 30&#45;day postoperatively Observation

Contacts

Public ContactWarangkana Lapisatepun

Faculty of Medicine Chiang Mai University

warangkana.c@cmu.ac.th0910688716

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026