NCT03516552

Brief Summary

Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.

Trial Health

87
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 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

April 15, 2018

Last Update Submit

August 5, 2019

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Differences on blood loss estimation.

    72 hours.

Study Arms (1)

Hemoglobin content on blood loss

Hemoglobin content on blood loss, to assess ratio hemoglobin/volume.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients electively scheduled for laparoscopic surgery.

You may qualify if:

  • \- Adults 18 - 90 yrs.

You may not qualify if:

  • Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
  • Surgical blood loss volume \< 200 ml.
  • Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
  • Transfusion of red blood cells (RBCs) during the perioperative period.
  • Significant postoperative bleeding (\> 50 ml in surgical drains) or any other type of significant blood loss.
  • Fluid infusions or vasoactive drugs after the first 24 postoperative hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 4, 2018

Study Start

January 1, 2018

Primary Completion

July 30, 2018

Study Completion

August 10, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)