TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock

NCT03837171 | Completed Phase 3 DMC

• 2 other identifiers: K170913J2018-A00592-53
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 20

Brief Summary

Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing. In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance. The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.

Conditions

Septic Shock; Anemia; Cancer

Keywords

Septic Shock; Anemia; cancer; erythrocyte transfusion

Outcome Measures

Primary Outcomes (1)

• Tissue oxygenation

  Percentage of patients with normal arterial lactate level at 12 hours (\<=2 mmol/L) or a relative decrease (or clearance) of arterial lactate level above 30% according to the formula (lactateH0 - lactateH12)/lactate H0\*100. lactateH0 : arterial lactate level at inclusion lactateH12 : arterial lactate level at 12h

  12 hours

Secondary Outcomes (19)

• Tissue oxygenation 6

  6 hours

• Tissue oxygenation 24

  24 hours

• Tissue oxygenation 48

  48 hours

• Mortality 7

  7 days

• Mortality 28

  28 days

Study Arms (2)

Liberal strategy

ACTIVE COMPARATOR

Maintain a hemoglobin level \> 9 g/dL during the first 48 hours of resuscitation of septic shock

Biological: Liberal Red blood cell transfusion

Restrictive strategy

EXPERIMENTAL

Maintain a hemoglobin level \> 7 g/dL during the resuscitation of septic shock

Biological: Restrictive Red blood cell transfusion

Interventions

Liberal Red blood cell transfusion BIOLOGICAL

Hemoglobin level will be maintained above 9 g/dL (liberal strategy) for the first 48 hours following randomization. After 48 hours, indications of RBC transfusions will be at the discretion of attending physicians in patients with persistent circulatory failure. After resolution of acute circulatory failure, a 7 g/dL transfusion threshold will be recommended regardless of the allocation arm. In case of subsequent episodes of septic shock, the transfusion strategy will be at the discretion of attending physicians

Liberal strategy

Restrictive Red blood cell transfusion BIOLOGICAL

Hemoglobin level will be maintained above 7 g/dL (restrictive strategy) during all the stay in ICU

Restrictive strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Evolutive (complete remission \< 2 years) malignant solid tumor or chronic or acute hematological malignancy
• Septic shock defined as:
• Presumed or documented infection
• Acute circulatory failure defined as hypotension requirement of vasoactive drugs for more than one hour (norepinephrine or epinephrine ≥ 0.1 µg/kg/min)
• Hemoglobin level \< 9 g/dL
• Informed consent from patients or surrogates

You may not qualify if:

• Acute life-threatening bleeding
• Ongoing acute coronary syndrome or any other acute ischemic condition
• End-of-life decisions at the time of ICU admission
• Refusal of transfusions for personal beliefs
• Lack of social security coverage
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (20)

CHU Amiens Picardie Site Sud

Amiens, France

Location

Hopital Robert Ballanger

Aulnay-sous-Bois, France

Location

Hopital Avicenne AP-HP

Bobigny, France

Location

CH sud-Francilien

Corbeil, France

Location

Hopital Henri Mondor AP-HP

Créteil, France

Location

CHV André Mignot

Le Chesnay, France

Location

Salengro, CHRU

Lille, France

Location

CH Lyon Sud

Lyon, France

Location

GH Édouard Herriot

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

GH Sud Ile de France

Melun, France

Location

Bel Air CHR

Metz, France

Location

Mercy, CHR

Metz, France

Location

CHU de Nantes

Nantes, France

Location

La Source, CHR

Orléans, France

Location

Hopital Cochin AP-HP

Paris, 75005, France

Location

Hopital de La Pitié Salpetriere AP-HP

Paris, France

Location

Hopital Saint Antoine AP-HP

Paris, France

Location

Hopital Saint Louis AP-HP

Paris, France

Location

Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Shock, Septic; Anemia; Neoplasms

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: March 24, 2019
• Primary Completion: February 28, 2024
• Study Completion: March 4, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

FR (20)