Blood Loss Quantification During Major Abdominal Surgery

Overview

Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.

Full Title of Study: “Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 30, 2022

Interventions

• Other: Measurement of external blood loss
  • Measurement of external blood loss
• Diagnostic Test: Serum Hemoglobin concentration
  • Serum Hemoglobin concentration

Arms, Groups and Cohorts

• HPB group
  • Adult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic.

Clinical Trial Outcome Measures

Primary Measures

• Blood loos quantification
  • Time Frame: 1 year
  • Estimated blood loss by surgeon (sEBL) Estimated blood loss by anesthesiologist (aEBL) Gravimetric blood loss weighted (vGBL) Calculated blood loos based on anthropometric and hematological parameters (vCBL) Spectrophotometric measured hemoglobin mass loss (hbMBL) Measured blood loss using using hbMBL and patient’s average pre- and postoperative serum hemoglobin (vMBL)

Secondary Measures

• Postoperative complications
  • Time Frame: 1 year
  • The effect of blood loss measured by spectrophotometric method on postoperative complications.

Participating in This Clinical Trial

Inclusion Criteria

• patient scheduled for liver or pancreatic surgery – age of patient ≥ 18 years – signed informed consent provided Exclusion Criteria:

• patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants). – use of cell saver suctioning during operation – damage/clotting of blood samples

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Defence, Faculty of Military Health Sciences
• Collaborator
  • University Hospital Hradec Kralove
• Provider of Information About this Clinical Study
  • Principal Investigator: Jan Zajak, Jan Zajak, MD, MA – University of Defence, Faculty of Military Health Sciences
• Overall Official(s)
  • Jan Zajak, MD, MA, Principal Investigator, University of Defence, Faculty of Military Health Sciences
• Overall Contact(s)
  • Jan Zajak, MD, MA, 00420495833620, jan.zajak@fnhk.cz