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CompletedNCT01172132Updated Apr 18, 2016

The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"

An observational study in Hematological Malignancies, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-18.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,011
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to determine:

  • Condition of intensive care unit (ICU) admission in patients with haematological malignancies.
  • ICU hospital and up to one year mortality.
  • Assessment of post ICU burden and health related quality at 90-d and 1 year.
Read the detailed description
  1. To identify prognostic factors of short and medium term mortality, by underlining the respective weights of organ dysfunction and characteristics of underlined malignancy
  2. Evaluate the health related quality of life of intensive care survivors(SF36)
  3. Impact of intensive care on families burden (HADS, IES).
  4. Assess clinicians' satisfaction ( intensivists, haematologists and intensive care nurses) in relation to medical decision-making.
  5. Establish the relevance of antifungal treatments.
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Conditions studied

  • Hematological Malignancies

Keywords

  • Leukemia
  • Lymphoma
  • Bone-Marrow Transplant
  • Neutropenia
  • Acute respiratory failure
  • Mechanical ventilation
  • Post ICU burden
  • ICU triage
  • Dialysis
  • Septic shock
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 1,011 is above the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with heamatological malignancy adressed to ICU

Inclusion criteria

  • Hematological malignancies
  • hospitalization in ICU
  • age >= 18 years

Exclusion criteria

Exclusion Criteria:

  • Patients who have already participated to TRIAL-OH
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,011 participants (actual)
06

What researchers measure

Primary outcomes

  1. Survival status at one year

    survival status (alive or death) at one year

    Time frame: 1 year

Secondary outcomes

  1. Health related quality of life of patients and their relatives

    Time frame: day 90 and 1 year

  2. ICU mortality

    survival status at ICU discharge

    Time frame: 1 week (estimated mean time until ICU discharge)

  3. Survival status

    Time frame: day 90

  4. Hospital mortality

    survival status at hospital discharge

    Time frame: 3 weeks (estimated mean time until Hospital discharge)

07

Study locations

1 site
  • Hôpital Saint-Louis, AP-HP
    Paris, 75475, France
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References and documents

Publications

  • Camous L, Lemiale V, Canet E, Max A, Schnell D, Le Goff J, Rabbat A, Schlemmer B, Azoulay E. Clinical features of H1N1 2009 infection in critically ill immunocompromised patients. Crit Care. 2010;14(2):139. doi: 10.1186/cc8927. Epub 2010 Apr 14. PubMed 20392286 ↗
  • Lemiale V, Resche-Rigon M, Mokart D, Pene F, Rabbat A, Kouatchet A, Vincent F, Bruneel F, Nyunga M, Lebert C, Perez P, Meert AP, Benoit D, Chevret S, Azoulay E. Acute respiratory failure in patients with hematological malignancies: outcomes according to initial ventilation strategy. A groupe de recherche respiratoire en reanimation onco-hematologique (Grrr-OH) study. Ann Intensive Care. 2015 Dec;5(1):28. doi: 10.1186/s13613-015-0070-z. Epub 2015 Sep 30. PubMed 26429355 ↗
  • Zafrani L, Resche-Rigon M, De Freitas Caires N, Gaudet A, Mathieu D, Parmentier-Decrucq E, Lemiale V, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, N'yunga M, Bruneel F, Rabbat A, Lebert C, Perez P, Meert AP, Benoit D, Darmon M, Azoulay E. Endothelial Cell-Specific Molecule-1 in Critically Ill Patients With Hematologic Malignancy. Crit Care Med. 2018 Mar;46(3):e250-e257. doi: 10.1097/CCM.0000000000002934. PubMed 29474336 ↗
  • Contejean A, Lemiale V, Resche-Rigon M, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Rabbat A, Perez P, Meert AP, Benoit D, Hamidfar R, Darmon M, Jourdain M, Renault A, Schlemmer B, Azoulay E. Increased mortality in hematological malignancy patients with acute respiratory failure from undetermined etiology: a Groupe de Recherche en Reanimation Respiratoire en Onco-Hematologique (Grrr-OH) study. Ann Intensive Care. 2016 Dec;6(1):102. doi: 10.1186/s13613-016-0202-0. Epub 2016 Oct 25. PubMed 27783381 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01172132
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 29, 2010
Start date
Nov 2009
Primary completion
May 2011
Completion
Nov 2011
Last update
Apr 18, 2016

Study contacts

Elie Azoulay, MD, PhD
principal investigator · Saint-Louis Hospital, Paris, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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