Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

Status Recruiting

Clinical Trial Summary

This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.

Clinical Trial Description

Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.

Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.

Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.

We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Hemorrhage

Clinical Trial Details

NCT number	NCT01709786
Study type	Observational
Source	University of Cincinnati
Contact	Betty J Tsuei, MD
Phone	513-558-5661
Email	betty.tsuei@uc.edu
Status	Recruiting
Phase	N/A
Start date	September 2012
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02815670` - Reversal Dabigatran Anticoagulant Effect With Idarucizumab	Phase 3
Completed	`NCT04588350` - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery	N/A
Recruiting	`NCT02972385` - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed	`NCT02554006` - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings	N/A
Completed	`NCT02569606` - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Recruiting	`NCT02446730` - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome	Phase 4
Completed	`NCT01955720` - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran	Phase 1
Completed	`NCT01935427` - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume	N/A
Completed	`NCT01191554` - Dose-ranging Study of Tranexamic Acid in Valve Surgery	N/A
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A
Completed	`NCT01136590` - Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery	Phase 4
Completed	`NCT01085006` - The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery	Phase 1/Phase 2
Completed	`NCT00700141` - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®	N/A
Completed	`NCT00375466` - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.	N/A
Completed	`NCT00479362` - Anticoagulant Therapy During Pacemaker Implantation	Phase 4
Completed	`NCT00147420` - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet	N/A
Recruiting	`NCT05945680` - Tranexamic Acid in Breast Esthetic Surgery.	Phase 4
Completed	`NCT03273322` - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure	Phase 2/Phase 3
Withdrawn	`NCT05672407` - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery	Phase 4
Not yet recruiting	`NCT05464394` - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.