Trial Outcomes & Findings for Phlebotomy to Prevent Blood Loss in Major Hepatic Resections (NCT NCT02548910)
NCT ID: NCT02548910
Last Updated: 2021-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
1 week prior to surgery (hemoglobin level), and day two of post-op (hemoglobin again).
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
Phlebotomy
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 14 • n=31 Participants
|
62 years
STANDARD_DEVIATION 11 • n=31 Participants
|
60 years
STANDARD_DEVIATION 12.6 • n=62 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=31 Participants
|
13 Participants
n=31 Participants
|
29 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=31 Participants
|
18 Participants
n=31 Participants
|
33 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
62 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 1 week prior to surgery (hemoglobin level), and day two of post-op (hemoglobin again).Population: incomplete data
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.
Outcome measures
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels
Anaesthetist Estimate
|
862 mL
Interval 451.0 to 1187.0
|
872 mL
Interval 525.0 to 1314.0
|
|
Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels
Surgeon Estimate
|
761 mL
Interval 451.0 to 1100.0
|
872 mL
Interval 557.0 to 1248.0
|
|
Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels
Calculated EBL
|
1116 mL
Interval 958.0 to 1526.0
|
1249 mL
Interval 778.0 to 1601.0
|
PRIMARY outcome
Timeframe: through study completion, an average of 2 yearsTrial accrual
Outcome measures
| Measure |
Phlebotomy
n=62 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Trial Feasibility
|
62 Participants
|
—
|
SECONDARY outcome
Timeframe: Will be measured in the operating room and in the first postoperative weekOutcome measures
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Blood Product Transfusion Rates
Total
|
5 Participants
|
4 Participants
|
|
Blood Product Transfusion Rates
Intraoperative
|
1 Participants
|
1 Participants
|
|
Blood Product Transfusion Rates
Postoperative
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Postoperative setting up to 30 days following surgeryOutcome measures
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Perioperative Morbidity (Dindo-Clavien Grade 3b of Higher) and Mortality
postoperative complications
|
10 Participants
|
15 Participants
|
|
Perioperative Morbidity (Dindo-Clavien Grade 3b of Higher) and Mortality
Major complication
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Will be measured in the operating roomPopulation: the number analyzed in one or more rows differs from overall number analyzed due to incomplete data
Outcome measures
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Changes in Physiologic Parameters (CVP)
before transection
|
8 cmH2O
Interval 4.5 to 9.5
|
7 cmH2O
Interval 6.0 to 9.0
|
|
Changes in Physiologic Parameters (CVP)
transection
|
8 cmH2O
Interval 5.0 to 10.0
|
7.5 cmH2O
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: Will be measured in the operating roomPopulation: the number analyzed in one or more rows differs from overall number analyzed due to incomplete data
Outcome measures
| Measure |
Phlebotomy
n=31 Participants
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 Participants
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Change in Physiologic Parameters (Cardiac Index)
Before transection
|
3.5 I per min per m2
Interval 3.0 to 4.1
|
4.2 I per min per m2
Interval 3.2 to 5.1
|
|
Change in Physiologic Parameters (Cardiac Index)
transection
|
3.5 I per min per m2
Interval 3.1 to 4.4
|
3.9 I per min per m2
Interval 3.1 to 5.1
|
Adverse Events
Phlebotomy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 2 deaths
Control
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phlebotomy
n=31 participants at risk
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 participants at risk
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
Renal and urinary disorders
Dialysis
|
0.00%
0/31 • adverse event data were collected for each participant for up to 30 days post surgery (intervention)
|
3.2%
1/31 • Number of events 1 • adverse event data were collected for each participant for up to 30 days post surgery (intervention)
|
Other adverse events
| Measure |
Phlebotomy
n=31 participants at risk
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.
Phlebotomy: 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.
Citrated whole blood collection bag: 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.
|
Control
n=31 participants at risk
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
|
|---|---|---|
|
General disorders
Postoperative compliations (Dindo-clavien grade I-II)
|
25.8%
8/31 • adverse event data were collected for each participant for up to 30 days post surgery (intervention)
|
38.7%
12/31 • adverse event data were collected for each participant for up to 30 days post surgery (intervention)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place