Method for Improved Intraoperative Blood Loss Estimates | NCT01634828

Studies
Method for Improved Intraoperative Blood Loss Estimates

NCT01634828

Sponsor

University of Utah

Status

Completed

Last Update Posted

May 12, 2016Estimated

Enrollment

47Actual

Phase

Not provided

Conditions

Improved Intraoperative Blood Loss Estimates

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
56181	Registry Identifier	IRB University of Utah

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jul 2, 2012

First Submission Date that Met QC Criteria

Jul 5, 2012

First Posted Date

Jul 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimate of intraoperative blood loss		duration of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All elective surgical patients

Exclusion Criteria:

Age < 18
Pregnant women
Prisoners
Lack of informed consent
Attending Physician feels enrollment could interfere with optimal patient care
Patients who did not have a preoperative hemoglobin measured as part of their preoperative work-up
Patients whose preoperative hemoglobin fraction is abnormal.
Patients who will likely require an intraoperative blood transfusion.
Patients for whom the intraoperative use of the Cell Saver is anticipated.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Elective surgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah		Salt Lake City	Utah	84132	United States

Label	Type	Description	Intervention Names
Minimal blood loss patients
Moderate to heavy blood loss patients