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NCT05316649 Clinical Trial

Blood Loss Quantification During Major Abdominal Surgery

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05316649
Other study ID # BloodMO0FVZ0000503
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date August 31, 2022

Study information
Verified date March 2022
Source University of Defence, Faculty of Military Health Sciences
Contact Jan Zajak, MD, MA
Phone 00420495833620
Email jan.zajak@fnhk.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date August 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Czechia University of Defence, Faculty of Military Health Sciences Hradec Králové

Sponsors (2)
Lead Sponsor Collaborator
University of Defence, Faculty of Military Health Sciences University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Postoperative complications The effect of blood loss measured by spectrophotometric method on postoperative complications. 1 year
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