Blood Loss Quantification During Major Abdominal Surgery

Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Blood Loss, Surgical; Blood Loss, Postoperative
• Intervention / Treatment: Other: Measurement of external blood loss; Diagnostic test: Serum Hemoglobin concentration

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Jan Zajak, MD, MA; Phone Number: 00420495833620; Email: jan.zajak@fnhk.cz

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50001
    • Recruiting
    • University of Defence, Faculty of Military Health Sciences
    • Contact: Jan Zajak, MD, MA; Email: jan.zajak@fnhk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing for elective liver or pancreas surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HPB group; Adult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic.	Other: Measurement of external blood loss; Measurement of external blood loss; Diagnostic test: Serum Hemoglobin concentration; Serum Hemoglobin concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loos quantification	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	The effect of blood loss measured by spectrophotometric method on postoperative complications.	1 year

Collaborators and Investigators

• Sponsor: University of Defence, Faculty of Military Health Sciences
• Collaborators: University Hospital Hradec Kralove
• Investigators: Principal Investigator: Jan Zajak, MD, MA, University of Defence, Faculty of Military Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Postoperative Complications; Blood Loss, Surgical; Postoperative Hemorrhage; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: BloodMO0FVZ0000503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No