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Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management

NCT01686659 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2018-04-23

No results posted yet for this study

Summary

This is a multi-center cluster-randomized trial with the following Specific Aims:

* To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
* To evaluate if patients monitored with continuous noninvasive hemoglobin experience less frequent complications and shorter hospital stay compared with patients who are not being monitored with continuous noninvasive hemoglobin.

Accordingly, the study hypotheses are defined as follows:

* The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will not reduce the RBC transfusions in patients undergoing surgeries associated with a significant risk of bleeding.
* The secondary hypothesis is that in patients monitored with continuous noninvasive hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus, there will be less frequent complications compared with patients who are not being monitored with continuous noninvasive hemoglobin.

Conditions

  • Surgery

Interventions

DEVICE

Continuous Noninvasive Hemoglobin Monitoring

Availability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin \[SpHb\] and Pleth Variability Index \[PVI\]) to the clinicians in the operating room

Sponsors & Collaborators

  • Society for the Advancement of Blood Management, Inc

    lead INDUSTRY

Principal Investigators

  • Aryeh Shander, MD · Englewood Hospital & Medical Center

  • Mazyar Javidroozi, MD, PhD · Englewood Hospital & Medical Center

  • Aryeh Shander, MD · Englewood Hospital & Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • United States
  • France
  • Italy
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686659 on ClinicalTrials.gov