Hematologic MalignancyCOHONCT03449953
Critical Care Outcomes of Hematologic Oncology Patients
An observational study of Hematologic Malignancy and Stem Cell Transplant, run by Mount Sinai Hospital, Canada at 13 sites in Canada.
Trial summary
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hematologic Malignancy, Stem Cell Transplant
- How many people
- 415 participants
- Where
- 13 sitesCanada
- Study dates
- 26 Feb 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hematologic malignancy (HM) and hematopoietic cell transplantation (HCT) frequently develop life-threatening illness and require admission to an intensive care unit (ICU). In light of advancements in care and extension of treatments to much higher risk candidates, survival and functional outcome evaluation become crucial for informed development of practice guidelines to guide pre-ICU risk stratification, as well as ICU and post-ICU care. Robust and up to date long-term data on ICU morbidity and mortality outcomes are lacking.
Who may be able to join
- Subjects >16 years with Hematologic Malignancy (HM) or post Stem Cell Transplant (HCT) who require ICU admission.
- HM includes: acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloma, lymphoma, myelofibrosis, and other myeloproliferative disorders or myelodysplastic syndromes.
- HCT is defined as the transplantation of multipotent hematopoietic stem cells from bone marrow, peripheral blood, or umbilical cord blood.
Who cannot join
- Subjects with significant preexisting neurological or psychiatric disease will be excluded from Phase 2 (1-year follow-up) but will be included in Phase 1.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Foothills Hospital
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2R3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
University Health Network
Toronto, Ontario, M5G 2M9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. There is little Canadian data regarding ICU survival and regarding 1-year survival and functional outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of up to date long-term outcome data. This information will facilitate a better understanding who would best benefit from critical care interventions and the impact of critical illness on their level of function at 1 year as well as survival.
Read the detailed description
At the time of ICU admission, the investigators will collect clinical data from the medical chart on a daily basis including demographics, pre-existing disease(s), treatment and reason for ICU admission.
At the time of ICU discharge, the investigators will measure exercise tolerance and quality of life at 3 time intervals (Phase 2).
For Phase 2, patients will be seen at day 7 following ICU discharge, 6 months following ICU discharge and 12 months after ICU discharge during their routine oncology follow up visits. During these visits, they will undergo a functional assessment (6 minute walk test) and questionnaires to determine their quality of life following ICU (validated outcome measures).
All patients will complete outcome measures 1 to 5 below; Outcome measures 1 to 3 will be administered at 7 days and 1 to 5 at 6 months and 12 months after ICU discharge.
Validated Outcomes Measures:
- Functional Independence Measure (FIM): a patient-centered measure of functional disability that captures burden of care on a daily basis and involves motor (FIM-motor) and cognitive function (FIM-cognition). FIM predicts disability outcome and rehabilitation needs in diverse patient populations.
- Six Minute Walk Test (6MWT) with continuous oximetry to measure the oxygen saturation of arterial blood will be performed to assess exercise capacity. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity because it uses an exercise mode that is relevant to everyday activities.
- Clinical Frailty Scale (CFS): CFS is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution. It is easy to administer in less than 5 minutes.
- Medical Outcomes Study Short Form - 36 Questionnaire (SF-36): SF-36 evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition. It has been validated in diverse patient populations and is a responsive and reproducible instrument; and can be completed in less than 15 minutes.
- FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
- Conditions
- Hematologic Malignancy, Stem Cell Transplant
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year survival
1 year survival in enrolled patients
Measured: 1 year
Secondary outcomes (11)
Intensive Care Unit survival
ICU survival in enrolled patients
Measured: 1 year
6 month functional outcome measured by the 6 minute walk test (6MWT)
6MWT will be performed to assess exercise capacity at 6 months
Measured: 6 months
6 month Functional Independent Measure questionnaire (FIM)
FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.
Measured: 6 months
6 month Clinical Frailty Scale (CFS)
CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution
Measured: 6 months
6 month Short Form 36 Health Questionnaire (SF 36)
SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition.
Measured: 6 months
6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Measured: 6 months
1 year functional outcome measured by the 6 minute walk test (6MWT)
6MWT will be performed to assess exercise capacity at 6 months
Measured: 1 year
1 year Functional Independent Measure questionnaire (FIM)
FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.
Measured: 1 year
1 year Clinical Frailty Scale (CFS)
CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution
Measured: 1 year
1 year Short Form 36 Health Questionnaire (SF 36)
SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition.
Measured: 1 year
1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start26 Feb 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- 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
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Laveena Munshi, MD, FRCPC, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449953
- Sponsor's protocol ID
- COHO vOct2017
- Acronym
- COHO
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2017
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guidelines for intensive care unit admission, discharge, and triage. Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med. 1999 Mar;27(3):633-8.
PubMed 10199547Roze des Ordons AL, Chan K, Mirza I, Townsend DR, Bagshaw SM. Clinical characteristics and outcomes of patients with acute myelogenous leukemia admitted to intensive care: a case-control study. BMC Cancer. 2010 Sep 28;10:516. doi: 10.1186/1471-2407-10-516.
PubMed 20920175Cornish M, Butler MB, Green RS. Predictors of Poor Outcomes in Critically Ill Adults with Hematologic Malignancy. Can Respir J. 2016;2016:9431385. doi: 10.1155/2016/9431385. Epub 2016 Feb 24.
PubMed 27445571Kraguljac AP, Croucher D, Christian M, Ibrahimova N, Kumar V, Jacob G, Kiss A, Minden MD, Mehta S. Outcomes and Predictors of Mortality for Patients with Acute Leukemia Admitted to the Intensive Care Unit. Can Respir J. 2016;2016:3027656. doi: 10.1155/2016/3027656. Epub 2016 Jun 30.
PubMed 27445524Trinkaus MA, Lapinsky SE, Crump M, Keating A, Reece DE, Chen C, Hallett DC, Franke N, Winter A, Mikhael JR. Predictors of mortality in patients undergoing autologous hematopoietic cell transplantation admitted to the intensive care unit. Bone Marrow Transplant. 2009 Mar;43(5):411-5. doi: 10.1038/bmt.2008.336. Epub 2008 Oct 20.
PubMed 18936734Scales DC, Thiruchelvam D, Kiss A, Sibbald WJ, Redelmeier DA. Intensive care outcomes in bone marrow transplant recipients: a population-based cohort analysis. Crit Care. 2008;12(3):R77. doi: 10.1186/cc6923. Epub 2008 Jun 11.
PubMed 18547422Yadav H, Nolan ME, Bohman JK, Cartin-Ceba R, Peters SG, Hogan WJ, Gajic O, Kor DJ. Epidemiology of Acute Respiratory Distress Syndrome Following Hematopoietic Stem Cell Transplantation. Crit Care Med. 2016 Jun;44(6):1082-90. doi: 10.1097/CCM.0000000000001617.
PubMed 26807683Thakkar SG, Fu AZ, Sweetenham JW, Mciver ZA, Mohan SR, Ramsingh G, Advani AS, Sobecks R, Rybicki L, Kalaycio M, Sekeres MA. Survival and predictors of outcome in patients with acute leukemia admitted to the intensive care unit. Cancer. 2008 May 15;112(10):2233-40. doi: 10.1002/cncr.23394.
PubMed 18348307Cuthbertson BH, Rajalingam Y, Harrison S, McKirdy F, On behalf of the Scottish Intensive Care Society. The outcome of haematological malignancy in Scottish intensive care units. JICS 2008; 9 (2)
Bird GT, Farquhar-Smith P, Wigmore T, Potter M, Gruber PC. Outcomes and prognostic factors in patients with haematological malignancy admitted to a specialist cancer intensive care unit: a 5 yr study. Br J Anaesth. 2012 Mar;108(3):452-9. doi: 10.1093/bja/aer449. Epub 2012 Jan 31.
PubMed 22298243Hampshire PA, Pugh R, Hajimichael P. Outcomes for critically ill patients with haematological malignancies in specialist and non-specialist centres in the United Kingdom. Journal of Cancer Therapeutics & Research 2014, http://www.hoajonline.com/journals/pdf/2049-7962-3-5.pdf
Grgic Medic M, Gornik I, Gasparovic V. Hematologic malignancies in the medical intensive care unit--Outcomes and prognostic factors. Hematology. 2015 Jun;20(5):247-53. doi: 10.1179/1607845414Y.0000000206. Epub 2014 Oct 13.
PubMed 25310461Azoulay E, Mokart D, Pene F, Lambert J, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Laisne LM, Rabbat A, Lebert C, Perez P, Chaize M, Renault A, Meert AP, Benoit D, Hamidfar R, Jourdain M, Darmon M, Schlemmer B, Chevret S, Lemiale V. Outcomes of critically ill patients with hematologic malignancies: prospective multicenter data from France and Belgium--a groupe de recherche respiratoire en reanimation onco-hematologique study. J Clin Oncol. 2013 Aug 1;31(22):2810-8. doi: 10.1200/JCO.2012.47.2365. Epub 2013 Jun 10.
PubMed 23752112Mokart D, Darmon M, Resche-Rigon M, Lemiale V, Pene F, Mayaux J, Rabbat A, Kouatchet A, Vincent F, Nyunga M, Bruneel F, Lebert C, Perez P, Renault A, Hamidfar R, Jourdain M, Meert AP, Benoit D, Chevret S, Azoulay E. Prognosis of neutropenic patients admitted to the intensive care unit. Intensive Care Med. 2015 Feb;41(2):296-303. doi: 10.1007/s00134-014-3615-y. Epub 2015 Jan 13.
PubMed 25578678Lengline E, Chevret S, Moreau AS, Pene F, Blot F, Bourhis JH, Buzyn A, Schlemmer B, Socie G, Azoulay E. Changes in intensive care for allogeneic hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2015 Jun;50(6):840-5. doi: 10.1038/bmt.2015.55. Epub 2015 Mar 23.
PubMed 25798675
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03449953
- Acronym / sponsor ID
- COHO / COHO vOct2017
- Conditions
- Hematologic Malignancy, Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. There is little Canadian data regarding ICU survival and regarding 1-year survival and functional outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of up to date long-term outcome data. This information will facilitate a better understanding who would best benefit from critical care interventions and the impact of critical illness on their level of function at 1 year as well as survival.
Detailed description
At the time of ICU admission, the investigators will collect clinical data from the medical chart on a daily basis including demographics, pre-existing disease(s), treatment and reason for ICU admission.
At the time of ICU discharge, the investigators will measure exercise tolerance and quality of life at 3 time intervals (Phase 2).
For Phase 2, patients will be seen at day 7 following ICU discharge, 6 months following ICU discharge and 12 months after ICU discharge during their routine oncology follow up visits. During these visits, they will undergo a functional assessment (6 minute walk test) and questionnaires to determine their quality of life following ICU (validated outcome measures).
All patients will complete outcome measures 1 to 5 below; Outcome measures 1 to 3 will be administered at 7 days and 1 to 5 at 6 months and 12 months after ICU discharge.
Validated Outcomes Measures:
- Functional Independence Measure (FIM): a patient-centered measure of functional disability that captures burden of care on a daily basis and involves motor (FIM-motor) and cognitive function (FIM-cognition). FIM predicts disability outcome and rehabilitation needs in diverse patient populations.
- Six Minute Walk Test (6MWT) with continuous oximetry to measure the oxygen saturation of arterial blood will be performed to assess exercise capacity. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity because it uses an exercise mode that is relevant to everyday activities.
- Clinical Frailty Scale (CFS): CFS is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution. It is easy to administer in less than 5 minutes.
- Medical Outcomes Study Short Form - 36 Questionnaire (SF-36): SF-36 evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition. It has been validated in diverse patient populations and is a responsive and reproducible instrument; and can be completed in less than 15 minutes.
- FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematologic malignancy (HM) and hematopoietic cell transplantation (HCT) frequently develop life-threatening illness and require admission to an intensive care unit (ICU). In light of advancements in care and extension of treatments to much higher risk candidates, survival and functional outcome evaluation become crucial for informed development of practice guidelines to guide pre-ICU risk stratification, as well as ICU and post-ICU care. Robust and up to date long-term data on ICU morbidity and mortality outcomes are lacking.
Key inclusion criteria (3 listed)
- Subjects >16 years with Hematologic Malignancy (HM) or post Stem Cell Transplant (HCT) who require ICU admission.
- HM includes: acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloma, lymphoma, myelofibrosis, and other myeloproliferative disorders or myelodysplastic syndromes.
- HCT is defined as the transplantation of multipotent hematopoietic stem cells from bone marrow, peripheral blood, or umbilical cord blood.
Key exclusion criteria (1 listed)
- Subjects with significant preexisting neurological or psychiatric disease will be excluded from Phase 2 (1-year follow-up) but will be included in Phase 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1 year survival
Time frame: 1 year
1 year survival in enrolled patients
11 secondary outcomes
Intensive Care Unit survival
Time frame: 1 year
6 month functional outcome measured by the 6 minute walk test (6MWT)
Time frame: 6 months
6 month Functional Independent Measure questionnaire (FIM)
Time frame: 6 months
6 month Clinical Frailty Scale (CFS)
Time frame: 6 months
6 month Short Form 36 Health Questionnaire (SF 36)
Time frame: 6 months
6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
Time frame: 6 months
1 year functional outcome measured by the 6 minute walk test (6MWT)
Time frame: 1 year
1 year Functional Independent Measure questionnaire (FIM)
Time frame: 1 year
1 year Clinical Frailty Scale (CFS)
Time frame: 1 year
1 year Short Form 36 Health Questionnaire (SF 36)
Time frame: 1 year
1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 10199547Guidelines for intensive care unit admission, discharge, and triage. Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med. 1999 Mar;27(3):633-8.
- Background: PubMed 20920175Roze des Ordons AL, Chan K, Mirza I, Townsend DR, Bagshaw SM. Clinical characteristics and outcomes of patients with acute myelogenous leukemia admitted to intensive care: a case-control study. BMC Cancer. 2010 Sep 28;10:516. doi: 10.1186/1471-2407-10-516.
- Background: PubMed 27445571Cornish M, Butler MB, Green RS. Predictors of Poor Outcomes in Critically Ill Adults with Hematologic Malignancy. Can Respir J. 2016;2016:9431385. doi: 10.1155/2016/9431385. Epub 2016 Feb 24.
- Background: PubMed 27445524Kraguljac AP, Croucher D, Christian M, Ibrahimova N, Kumar V, Jacob G, Kiss A, Minden MD, Mehta S. Outcomes and Predictors of Mortality for Patients with Acute Leukemia Admitted to the Intensive Care Unit. Can Respir J. 2016;2016:3027656. doi: 10.1155/2016/3027656. Epub 2016 Jun 30.
- Background: PubMed 18936734Trinkaus MA, Lapinsky SE, Crump M, Keating A, Reece DE, Chen C, Hallett DC, Franke N, Winter A, Mikhael JR. Predictors of mortality in patients undergoing autologous hematopoietic cell transplantation admitted to the intensive care unit. Bone Marrow Transplant. 2009 Mar;43(5):411-5. doi: 10.1038/bmt.2008.336. Epub 2008 Oct 20.
- Background: PubMed 18547422Scales DC, Thiruchelvam D, Kiss A, Sibbald WJ, Redelmeier DA. Intensive care outcomes in bone marrow transplant recipients: a population-based cohort analysis. Crit Care. 2008;12(3):R77. doi: 10.1186/cc6923. Epub 2008 Jun 11.
- Background: PubMed 26807683Yadav H, Nolan ME, Bohman JK, Cartin-Ceba R, Peters SG, Hogan WJ, Gajic O, Kor DJ. Epidemiology of Acute Respiratory Distress Syndrome Following Hematopoietic Stem Cell Transplantation. Crit Care Med. 2016 Jun;44(6):1082-90. doi: 10.1097/CCM.0000000000001617.
- Background: PubMed 18348307Thakkar SG, Fu AZ, Sweetenham JW, Mciver ZA, Mohan SR, Ramsingh G, Advani AS, Sobecks R, Rybicki L, Kalaycio M, Sekeres MA. Survival and predictors of outcome in patients with acute leukemia admitted to the intensive care unit. Cancer. 2008 May 15;112(10):2233-40. doi: 10.1002/cncr.23394.
- BackgroundCuthbertson BH, Rajalingam Y, Harrison S, McKirdy F, On behalf of the Scottish Intensive Care Society. The outcome of haematological malignancy in Scottish intensive care units. JICS 2008; 9 (2)
- Background: PubMed 22298243Bird GT, Farquhar-Smith P, Wigmore T, Potter M, Gruber PC. Outcomes and prognostic factors in patients with haematological malignancy admitted to a specialist cancer intensive care unit: a 5 yr study. Br J Anaesth. 2012 Mar;108(3):452-9. doi: 10.1093/bja/aer449. Epub 2012 Jan 31.
- BackgroundHampshire PA, Pugh R, Hajimichael P. Outcomes for critically ill patients with haematological malignancies in specialist and non-specialist centres in the United Kingdom. Journal of Cancer Therapeutics & Research 2014, http://www.hoajonline.com/journals/pdf/2049-7962-3-5.pdf
- Background: PubMed 25310461Grgic Medic M, Gornik I, Gasparovic V. Hematologic malignancies in the medical intensive care unit--Outcomes and prognostic factors. Hematology. 2015 Jun;20(5):247-53. doi: 10.1179/1607845414Y.0000000206. Epub 2014 Oct 13.
- Individual participant dataSharing planned: No
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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.
Dr. Laveena Munshi, MD, FRCPC principal investigator
MOUNT SINAI HOSPITAL
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy and Stem Cell Transplant, run by Mount Sinai Hospital, Canada at 13 sites 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
1 year survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449953, which also lists 39 linked publications.
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 27 Nov 2024.