Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

NCT03740438 | Completed

• 1 other identifier: HCB/2016/0906/2
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.

Conditions

Surgical Blood Loss; Surgery; Perioperative/Postoperative Complications

Keywords

Hemoglobin; Hemoglobin drop; Surgical Blood loss

Outcome Measures

Primary Outcomes (1)

• Hemoglobin concentration

  Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)

  2-5 days

Interventions

Hemoglobin concentration DIAGNOSTIC_TEST

Perioperative hemogloin concentration

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 electively scheduled for laparoscopic urologic and gynecologic surgery.

You may qualify if:

• Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.

You may not qualify if:

• Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
• Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
• Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period.
• Significant postoperative bleeding (\> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss).
• Postoperative hemodynamic instability (defined as requirement of vasoactive drugs).
• Other major postoperative complications during the observable period.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Complications

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 14, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 2, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

ES (1)