- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249038
Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
October 27, 2024 updated by: Sebastian Jaramillo, Hospital Clinic of Barcelona
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for elective urologic laparoscopy surgery.
Description
Inclusion Criteria:
- Patients scheduled for elective urologic laparoscopy surgery.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hemoglobin mass lost
Time Frame: Intraoperative
|
Intraoperative
|
|
Postoperative serum hemoglobin concentration
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
August 10, 2017
First Submitted That Met QC Criteria
August 10, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 27, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Intraoperative Complications
- Hemorrhage
- Blood Loss, Surgical
- Postoperative Hemorrhage
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Chrysarobin
Other Study ID Numbers
- HCB/2016/0906
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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