Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Perioperative/Postoperative Complications; Surgical Blood Loss
• Intervention / Treatment: Diagnostic test: Hemoglobin concentration

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Sebastian Jaramillo, MD; Phone Number: 932275558; Email: jaramillo@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Sebastian Jaramillo, MD; Email: jaramillo@clinic.cat

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 electively scheduled for laparoscopic urologic and gynecologic surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentration	Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)	2-5 days

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 11, 2018
• First Posted (ACTUAL): November 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Hemoglobin; Hemoglobin drop; Surgical Blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Postoperative Complications; Blood Loss, Surgical; 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: HCB/2016/0906/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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