CancerTHRRIVESNCT01848912
Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)
An observational study of Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Zephyr Biopatch Device
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an expected prolonged period of neutropenia completing bone marrow transplant (including both allogeneic and autologous) or induction chemotherapy
Who may be able to join
- An expected prolonged period of neutropenia
- Completing bone marrow;
- Allogeneic and/or autologous transplants OR
- Induction chemotherapy
Who cannot join
- Inability to obtain written informed consent from patient or legally authorized representative
- Ongoing treatment for active infection (not prophylaxis)
- Preexisting severe cardiopulmonary disease (defined as an EF 40%, FEV 40%,or interstitial lung disease with pulmonary fibrosis)
- On betablockers or calcium channel blockers
- Preexisting arrhythmia
- Permanent pacemaker
- Inability to speak neither English nor French
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus
Ottawa, Ontario
About this study
The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. The investigators are collecting data to determine whether or not subtle differences in heart rate, respiratory rate and temperature will help physicians to detect infection earlier in order to begin faster treatment before a patient's condition deteriorates. Blood tests will also be performed to check for certain biomarkers that may indicate infection
Read the detailed description
In this prospective observational study, patients receiving bone marrow transplant are selected for continuous monitoring of heart rate, respiratory and temperate variability. Data is collected as per standard practice using the Zephyr Biopatch device, a highly compact wireless monitor with two small gel electrodes, that is much more comfortable than previous belt/strap-based monitoring devices.
The patient is asked to wear the Zephyr Biopatch device for approximately 23 hours a day, beginning the day before he/she begins bone marrow transplant. The patient is asked to continue wearing the device for a period of up to 10 days or until he/she is no longer experiencing any fever. The Zephyr Biopatch device records heart rate, respiratory rate and temperature for calculation of heart rate variability (HRV), respiratory rate variability (RRV) and temperature variability (TV) using the Continuous Multiorgan Individualized Variability Analysis (CIMVATM) software engine. The variability outcomes will look at the presence, rapidity and severity of change in variability prior to the onset, diagnosis and treatment of infection. Bloodwork will also be performed to check for certain biomarkers that may indicate infection.
- Conditions
- Cancer
- Being tested
- Zephyr Biopatch Device
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zephyr Biopatch DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Transplant Patients | Not described Receives: Device: Zephyr Biopatch Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation or broadening of antibiotic for the purpose of treatment of infection
Measured: Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days
Secondary outcomes (1)
Admission to ICU with organ failure or hospital
Measured: Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Christopher Bredeson, MD, MSc, Principal investigator, Ottawa Hospital Research InstituteAndrew Seely, MD, PhD, Study director, Ottawa Hospital Research InstituteBill Cameron, MD, FRCPC, Study chair, Ottawa Hospital Research InstituteTim Ramsay, MSc, PhD, Study chair, Ottawa Hospital Research InstituteLauralyn McIntyre, MD MSc, Study chair, Ottawa Hospital Research InstituteLothar Huebsch, MD, Study chair, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848912
- Sponsor's protocol ID
- 20120564-01H
- Acronym
- THRRIVES
- Status last verified
- Nov 2022
- First submitted
- 18 Apr 2013
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)
- ClinicalTrials.gov ID
- NCT01848912
- Acronym / sponsor ID
- THRRIVES / 20120564-01H
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- Mar 2013
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. The investigators are collecting data to determine whether or not subtle differences in heart rate, respiratory rate and temperature will help physicians to detect infection earlier in order to begin faster treatment before a patient's condition deteriorates. Blood tests will also be performed to check for certain biomarkers that may indicate infection
Detailed description
In this prospective observational study, patients receiving bone marrow transplant are selected for continuous monitoring of heart rate, respiratory and temperate variability. Data is collected as per standard practice using the Zephyr Biopatch device, a highly compact wireless monitor with two small gel electrodes, that is much more comfortable than previous belt/strap-based monitoring devices.
The patient is asked to wear the Zephyr Biopatch device for approximately 23 hours a day, beginning the day before he/she begins bone marrow transplant. The patient is asked to continue wearing the device for a period of up to 10 days or until he/she is no longer experiencing any fever. The Zephyr Biopatch device records heart rate, respiratory rate and temperature for calculation of heart rate variability (HRV), respiratory rate variability (RRV) and temperature variability (TV) using the Continuous Multiorgan Individualized Variability Analysis (CIMVATM) software engine. The variability outcomes will look at the presence, rapidity and severity of change in variability prior to the onset, diagnosis and treatment of infection. Bloodwork will also be performed to check for certain biomarkers that may indicate infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Transplant Patients | – | Device: Zephyr Biopatch Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an expected prolonged period of neutropenia completing bone marrow transplant (including both allogeneic and autologous) or induction chemotherapy
Key inclusion criteria (4 listed)
- An expected prolonged period of neutropenia
- Completing bone marrow;
- Allogeneic and/or autologous transplants OR
- Induction chemotherapy
Key exclusion criteria (7 listed)
- Inability to obtain written informed consent from patient or legally authorized representative
- Ongoing treatment for active infection (not prophylaxis)
- Preexisting severe cardiopulmonary disease (defined as an EF 40%, FEV 40%,or interstitial lung disease with pulmonary fibrosis)
- On betablockers or calcium channel blockers
- Preexisting arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zephyr Biopatch Device | Device | Bone Marrow Transplant Patients |
Primary outcome
Initiation or broadening of antibiotic for the purpose of treatment of infection
Time frame: Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days
1 secondary outcome
Admission to ICU with organ failure or hospital
Time frame: Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bredeson, MD, MSc principal investigator
Ottawa Hospital Research Institute
Andrew Seely, MD, PhD study director
Ottawa Hospital Research Institute
Bill Cameron, MD, FRCPC study chair
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation or broadening of antibiotic for the purpose of treatment of infection (time frame: Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.