N/A
Completed N=62
Phlebotomy to Prevent Blood Loss in Major Hepatic Resections
Source: ClinicalTrials.gov NCT02548910 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Mar 2021
Primary outcomePrimary: Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels — 862; 872; 761; 872 mL
Summary
Major liver resection is associated with substantial intraoperative blood loss. Blood loss in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels |
862; 872; 761; 872; 1116; 1249 | — |
| PRIMARY Trial Feasibility |
62 | — |
| SECONDARY Blood Product Transfusion Rates |
1; 1; 5; 3; 5; 4 | — |
| SECONDARY Perioperative Morbidity (Dindo-Clavien Grade 3b of Higher) and Mortality |
10; 15; 2; 3 | — |
| SECONDARY Changes in Physiologic Parameters (CVP) |
8; 7; 8; 7.5 | — |
| SECONDARY Change in Physiologic Parameters (Cardiac Index) |
3.5; 4.2; 3.5; 3.9 | — |
Eligibility Criteria
Inclusion Criteria
- Any patient being considered for a major elective liver resection will be considered for trial enrollment. Patients who are undergoing a concurrent additional abdominal or thoracic procedure (eg. colonic resection) will also be included.
Exclusion Criteria
- Age 1.5 not on warfarin and/or platelets count 35 umol/L)
- Presence of active infection
- Preoperative autologous blood donation
- Hemoglobin <100 g/L
Data sourced from ClinicalTrials.gov (NCT02548910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.