NCT03249038

Brief Summary

Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

August 10, 2017

Last Update Submit

October 27, 2024

Conditions

Blood Loss, SurgicalBlood LossBlood Loss, Postoperative

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin mass lost

    Intraoperative

  • Postoperative serum hemoglobin concentration

    48 hours

Interventions

Measurement of external blood lossOTHER
Serum Hemoglobin concentrationDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective urologic laparoscopy surgery.

You may qualify if:

  • Patients scheduled for elective urologic laparoscopy surgery.

You may not qualify if:

  • Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
  • Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
  • Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Serum hemoglobin concentration. * Hemoglobin concentration of external blood loss.

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhagePostoperative Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsPostoperative Complications

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sebastian Jaramillo

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share