Evidence map›Paper›PMID 36653812›Full record

ArticleTrials2023

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial.

Guillaume Martel, Tori Lenet, Christopher Wherrett, François-Martin Carrier, Leah Monette, Aklile Workneh, Karine Brousseau, Monique Ruel, Michaël Chassé, Yves Collin and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03651154 (PRICE 2), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03651154 naactive not recruitingnot on this map

PRICE 2: A Phase 3 Randomized Controlled Trial of Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2018 to 2026Enrolled440ConditionsLiver Neoplasms, Hepatectomy, Blood Transfusion, Blood Loss, SurgicalArmsHypovolemic Phlebotomy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Guideline
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 5 institutions in 1 country.

Guillaume MartelLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada. gumartel@toh.ca.ORCID http://orcid.org/0000-0002-1242-2601
Tori LenetLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Christopher WherrettDepartments of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.
François-Martin CarrierDepartment of Anesthesiology, Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
Leah MonetteLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Aklile WorknehLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Karine BrousseauLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Monique RuelDepartment of Anesthesiology, Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
Michaël ChasséDepartment of Medicine, Critical Care Division, Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
Yves CollinDivision of General Surgery, Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Franck Vandenbroucke-MenuHepato-Pancreato-Biliary and Liver Transplantation Surgery Unit, Department of Surgery - Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
Élodie Hamel-PerreaultDepartement of Anesthesiology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Michel-Antoine PerreaultDepartement of Anesthesiology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Jeieung ParkDepartment of Anesthesiology and Perioperative Care, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Shirley LimDepartment of Anesthesiology and Perioperative Care, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Véronique MaltaisDepartment of Surgery, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Philemon LeungDepartment of Surgery, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Richard W D GilbertDepartment of Surgery, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Maja SegediDepartment of Surgery, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Jad Abou-KhalilLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Kimberly A BertensLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Fady K BalaaLiver and Pancreas Unit, Department of Surgery, The Ottawa Hospital- General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, Ottawa, ON, K1H 8L6, Canada.
Tim RamsayClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Dean A FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
University of Ottawa · CAUniversity of British Columbia · CACentre Hospitalier de l’Université de Montréal · CACentre Hospitalier Universitaire de Sherbrooke · CAOttawa Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBlood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection.

methodsThis study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION: The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs.

trial registrationClinicalTrials.gov NCT03651154 . Registered on August 29 2018.

Indexed as

HypovolemiaPhlebotomyAdultBlood TransfusionCanadaClinical Trials, Phase III as TopicHumansLiverMulticenter Studies as TopicRandomized Controlled Trials as TopicAutologous blood transfusionBlood lossBlood transfusionHemodilutionHepatectomyHypovolemiaLiver resectionPhlebotomyRandomized controlled trial

Identifiers

PMID36653812
PMCPMC9848035
OpenAlexW4317234227

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.