Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

Surgery Clinical Trial

Official title:

Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740438
• Other study ID #: HCB/2016/0906/2
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: August 2019
• Source: Hospital Clinic of Barcelona
• Contact: Sebastian Jaramillo, MD
• Phone: 932275558
• Email: jaramillo[@]clinic.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Perioperative/Postoperative Complications
• Postoperative Complications
• Surgery
• Surgical Blood Loss

Intervention

Diagnostic Test:
• Hemoglobin concentration
Perioperative hemogloin concentration

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentration	Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)	2-5 days