Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management (NACHO)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01686659 |
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Recruitment Status :
Recruiting
First Posted : September 18, 2012
Last Update Posted : April 23, 2018
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Sponsor:
Society for the Advancement of Blood Management, Inc
Information provided by (Responsible Party):
Society for the Advancement of Blood Management, Inc
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 29, 2012 | |||||||||
| First Posted Date ICMJE | September 18, 2012 | |||||||||
| Last Update Posted Date | April 23, 2018 | |||||||||
| Study Start Date ICMJE | September 2012 | |||||||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Amount of Intraoperative RBC Transfusion [ Time Frame: From the first surgical incision to the wound closure ] Number of allogeneic RBC units transfused intraoperatively per patient
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01686659 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management | |||||||||
| Official Title ICMJE | Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management | |||||||||
| Brief Summary | This is a multi-center cluster-randomized trial with the following Specific Aims:
Accordingly, the study hypotheses are defined as follows:
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| Detailed Description | This is a matched-pair cluster-randomized controlled trial. At each participating centers, consenting eligible Anesthesiologists will be grouped into matched pairs based on their practice characteristics and experience (namely, their main surgical service/procedures and their years of experience working as a clinician responsible for making transfusion decisions). From each pair, Anesthesiologists will be randomly allocated to either treat their patients while having access to data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) (SpHb group) or without access to SpHb/PVI data, under standard of care (control group). Regardless of randomization, all patients will be monitored with the device but the data will be blinded and not be available to the Anesthesiologist to be used in the management of the control group. Only in the SpHb group, the SpHb/PVI data will be provided live to the Anesthesiologist, to be used during management of the patients. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE | Surgery | |||||||||
| Intervention ICMJE | 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
Other Names:
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
470 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | June 2019 | |||||||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France, Italy, Japan, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01686659 | |||||||||
| Other Study ID Numbers ICMJE | NACHO | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Society for the Advancement of Blood Management, Inc | |||||||||
| Study Sponsor ICMJE | Society for the Advancement of Blood Management, Inc | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Society for the Advancement of Blood Management, Inc | |||||||||
| Verification Date | April 2018 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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