Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections (PRICE2)
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|ClinicalTrials.gov Identifier: NCT03651154|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Liver Neoplasms Hepatectomy Blood Transfusion Blood Loss, Surgical||Procedure: Hypovolemic Phlebotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||PRICE 2: A Phase 3 Randomized Controlled Trial of Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Hypovolemic Phlebotomy
Hypovolemic Phlebotomy will consist of the withdrawal of 7-10 mL/kg of whole blood from the patient, as tolerated (e.g. for a 70kg patient, 490 to 700 mL of whole blood will be removed) The volume of removed blood will not be replaced by the administration of intravenous fluids.
Removed blood will be transfused back to participant at the end of surgery. The phlebotomized whole blood will be transfused back after liver transection regardless of blood loss.
Procedure: Hypovolemic Phlebotomy
Removal of 7-10ml/kg of blood from participant, as tolerated after patient is under anesthesia, before liver resection start time
No Intervention: Control (Standard of Care)
Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
- Packed Red Blood Cell Transfusion Rates [ Time Frame: 30 days post-operation ]Units of packed red blood cells transfused to participants
- Blood product transfusion rates [ Time Frame: Postoperative setting up to 30 days following surgery ]Types and amount of other blood product transfusion rates in the 30 day period following surgery.
- Intraoperative blood loss [ Time Frame: up to 90 days before surgery; and on post-operative day 2 ]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.
- Perioperative morbidity and mortality [ Time Frame: Postoperative setting up to 30 days following surgery ]Perioperative morbidity is assessed using the Dindo-Clavien scale and is defined as any deviation from the normal post-operative course. The scale (1-5) indicates the severity of an adverse event; where 1 is low (i.e. "any deviation from normal postoperative course without the need for intervention") and 5 means death of the patient (i.e. mortality).
- Changes in physiologic parameters (Central Venous Pressure) [ Time Frame: measured during surgery (intraoperatively) ]Central venous pressure (CVP) is a physiologic parameter that measures the blood pressure in the thoracic vena cava (in cm H20)
- Changes in physiologic parameters (Pulse Pressure Variation) [ Time Frame: measured during surgery (intraoperatively) ]Pulse Pressure variation (in %) is a predictor of fluid responsiveness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651154
|Contact: Aklile Workneh, MSc||6137378899 ext firstname.lastname@example.org|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Guillaume Martel, MD, MSc, FRCSC, FACS 6137378899 ext 71053 email@example.com|
|Contact: Aklile Workneh, MSc 6137378899 ext 71484 firstname.lastname@example.org|
|Principal Investigator: Guillaume Martel, MD, MSc, FRCSC, FACS|
|Centre Hospitalier de l"Université de Sherbrooke||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Yves Collins, MD|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montréal, Quebec, Canada|
|Contact: François Carrier, MD|
|Principal Investigator:||Guillaume Martel, MD, MSc, FRCSC, FACS||Ottawa Hospital Research Institute|