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Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249038
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sebastian Jaramillo, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment
Blood Loss, Surgical Blood Loss Blood Loss, Postoperative Other: Measurement of external blood loss Diagnostic Test: Serum Hemoglobin concentration

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Hemoglobin mass lost [ Time Frame: Intraoperative ]
  2. Postoperative serum hemoglobin concentration [ Time Frame: 48 hours ]

Biospecimen Retention:   Samples Without DNA
  • Serum hemoglobin concentration.
  • Hemoglobin concentration of external blood loss.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective urologic laparoscopy surgery.
Criteria

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.
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Responsible Party: Sebastian Jaramillo, Dr. Sebastian Jaramillo, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03249038    
Other Study ID Numbers: HCB/2016/0906
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications