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OpenTrials
Completed

NCT Number: NCT03740438

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.

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Key information

Conditions

Surgical Blood Loss Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemoglobin concentration

Diagnostic Test

Perioperative hemogloin concentration

Primary outcomes

  1. Hemoglobin concentration

    Time frame: 2-5 days

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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2018
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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