Blood Loss Quantification During Major Abdominal Surgery

NCT05316649 | Unknown

• 1 other identifier: BloodMO0FVZ0000503
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss, Surgical; Blood Loss, Postoperative; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications

  1 year

Study Arms (1)

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; Diagnostic Test: Serum Hemoglobin concentration

Interventions

Measurement of external blood loss OTHER

Measurement of external blood loss

HPB group

Serum Hemoglobin concentration DIAGNOSTIC_TEST

Serum Hemoglobin concentration

HPB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing for elective liver or pancreas surgery.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Defence, Faculty of Military Health Sciences: lead
• University Hospital Hradec Kralove: collaborator

Study Sites (1)

University of Defence, Faculty of Military Health Sciences

Hradec Králové, 50001, Czechia

RECRUITING

Related Publications (1)

• Zajak J, Paral J, Sirovy M, Odlozilova S, Vinklerova K, Lochman P, Cecka F. Blood loss quantification during major abdominal surgery: prospective observational cohort study. BMC Surg. 2024 Jan 2;24(1):5. doi: 10.1186/s12893-023-02288-w.

  PMID: 38166991 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Hemoglobin concentration Suctioned fluid Hemoglobin concentration

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage; Postoperative Complications

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Jan Zajak, MD, MA

  University of Defence, Faculty of Military Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Zajak, MD, MA

CONTACT

00420495833620; jan.zajak@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jan Zajak, MD, MA

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)