An interventional study of Phlebotomy and Citrated whole blood collection bag in Liver Neoplasms and Hepatectomy, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Prevention
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.
Major liver resection is associated with significant intraoperative blood loss. Blood loss in elective liver surgery is a key determinant of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. Whole blood phlebotomy is a simple intervention, whose aim is to decrease the central venous pressure yielding a state of relative hypovolemia and thus lead to decreased blood loss. Small studies, mostly from the liver transplant literature, would suggest that phlebotomy with controlled hypovolemia can result in decreased blood loss and blood transfusion. Since blood loss is an important issue in liver surgery, and the benefits of phlebotomy and controlled hypovolemia are unknown in liver resection patients, a rigorously conducted trial in a representative population of patients undergoing liver resection is warranted, and feasible. In this proposal, it is hypothesized that by the use of phlebotomy and controlled hypovolemia, it is possible to decrease blood loss and blood transfusions. To test this hypothesis the investigators plan to randomly allocate participants to phlebotomy plus standard of care or to standard of care. Participants will be those patients undergoing elective major liver resection at the Ottawa Hospital for any indication. The primary outcome will be intraoperative blood loss. Secondary outcomes will include transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. A total of 62 patients will be randomized. The efficacy of phlebotomy in terms of blood loss prevention will be assessed.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 62 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
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Exclusion Criteria:
For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.
Procedure: Phlebotomy · Device: Citrated whole blood collection bag
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.
Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood.
Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels
Intraoperative blood loss is notoriously difficult to measure. It is suggested that calculation of blood loss using preoperative and postoperative hemoglobin levels in most consistently accurate. In order to minimize the risk of bias associated with any one method of intraoperative measurement of blood loss, three methods will be used independently. In the operating room, all blood and fluid aspirated from the abdomen will be measured accurately using graduated suction containers. As well, the amount of irrigation fluid will be carefully monitored and recorded. Finally, the weight of all surgical sponges will be measured. This information will be used by the surgeon and anesthesiologist to independently visually estimate blood loss, as is commonly done in clinical practice. In parallel, intraoperative blood loss will also be calculated based on an equation.
Time frame: 1 week prior to surgery (hemoglobin level), and day two of post-op (hemoglobin again).
Trial Feasibility
Trial accrual
Time frame: through study completion, an average of 2 years
Blood Product Transfusion Rates
Time frame: Will be measured in the operating room and in the first postoperative week
Perioperative Morbidity (Dindo-Clavien Grade 3b of Higher) and Mortality
Time frame: Postoperative setting up to 30 days following surgery
Changes in Physiologic Parameters (CVP)
Time frame: Will be measured in the operating room
Change in Physiologic Parameters (Cardiac Index)
Time frame: Will be measured in the operating room
| Milestone | Phlebotomy | Control |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
Intraoperative blood loss is notoriously difficult to measure. It is suggested that calculation of blood loss using preoperative and postoperative hemoglobin levels in most consistently accurate. In order to minimize the risk of bias associated with any one method of intraoperative measurement of blood loss, three methods will be used independently. In the operating room, all blood and fluid aspirated from the abdomen will be measured accurately using graduated suction containers. As well, the amount of irrigation fluid will be carefully monitored and recorded. Finally, the weight of all surgical sponges will be measured. This information will be used by the surgeon and anesthesiologist to independently visually estimate blood loss, as is commonly done in clinical practice. In parallel, intraoperative blood loss will also be calculated based on an equation.
| mL | Phlebotomy | Control |
|---|---|---|
| Anaesthetist Estimate | 862 (451 to 1187) | 872 (525 to 1314) |
| Surgeon Estimate | 761 (451 to 1100) | 872 (557 to 1248) |
| Calculated EBL | 1116 (958 to 1526) | 1249 (778 to 1601) |
Trial accrual
| Participants | Participant Accrual |
|---|---|
| Trial Feasibility | 62 |
| Participants | Phlebotomy | Control |
|---|---|---|
| Intraoperative | 1 | 1 |
| Postoperative | 5 | 3 |
| Total | 5 | 4 |
| Participants | Phlebotomy | Control |
|---|---|---|
| postoperative complications | 10 | 15 |
| Major complication | 2 | 3 |
| cmH2O | Phlebotomy | Control |
|---|---|---|
| before transection | 8 (4.5 to 9.5) | 7 (6 to 9) |
| transection | 8 (5 to 10) | 7.5 (5 to 10) |
| I per min per m2 | Phlebotomy | Control |
|---|---|---|
| Before transection | 3.5 (3.0 to 4.1) | 4.2 (3.2 to 5.1) |
| transection | 3.5 (3.1 to 4.4) | 3.9 (3.1 to 5.1) |
Collected over adverse event data were collected for each participant for up to 30 days post surgery (intervention). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phlebotomy | 2/31 (6.5%) | 0/31 (0%) | 8/31 (25.8%) |
| Control | 1/31 (3.2%) | 1/31 (3.2%) | 12/31 (38.7%) |
| Event | Phlebotomy | Control |
|---|---|---|
| DialysisRenal and urinary disorders | 0/31 | 1/31 |
| Event | Phlebotomy | Control |
|---|---|---|
| Postoperative compliations (Dindo-clavien grade I-II)General disorders | 8/31 | 12/31 |
| Age, Continuous(years) | Phlebotomy | Control | Total |
|---|---|---|---|
| Mean | 58 ± 14 | 62 ± 11 | 60 ± 12.6 |
| Sex: Female, Male(Participants) | Phlebotomy | Control | Total |
|---|---|---|---|
| Female | 16 | 13 | 29 |
| Male | 15 | 18 | 33 |
| Race and Ethnicity Not Collected(Participants) | Phlebotomy | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Phlebotomy | Control | Total |
|---|---|---|---|
| Canada | 31 | 31 | 62 |
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Ottawa Hospital Research Institute