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Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

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ClinicalTrials.gov Identifier: NCT03740438
Recruitment Status : Unknown
Verified August 2019 by Sebastian Jaramillo, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : November 14, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sebastian Jaramillo, Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment
Surgical Blood Loss Surgery Perioperative/Postoperative Complications Diagnostic Test: Hemoglobin concentration

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Days
Official Title: Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Hemoglobin concentration
    Perioperative hemogloin concentration

Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin concentration [ Time Frame: 2-5 days ]
    Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740438


Contacts
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Contact: Sebastian Jaramillo, MD 932275558 jaramillo@clinic.cat

Locations
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Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Sebastian Jaramillo, MD       jaramillo@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
More Information
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Additional Information:

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Responsible Party: Sebastian Jaramillo, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03740438    
Other Study ID Numbers: HCB/2016/0906/2
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastian Jaramillo, Hospital Clinic of Barcelona:
Hemoglobin
Hemoglobin drop
Surgical Blood loss
Additional relevant MeSH terms:
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Hemorrhage
Postoperative Complications
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications