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Transfusion Related ComplicationPhase 31VERSUS2CGRNCT02461264

Transfusion Strategy in Hematological Intensive Care Unit

A Phase 3 study testing Single red blood packed cells Transfusion and Two packed red blood cells Transfusion in people with Transfusion Related Complication, run by University Hospital, Caen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transfusion Related Complication
What is being tested?
Single red blood packed cells Transfusion and Two packed red blood cells Transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteFrance
Study dates
Jan 2016to Sep 2019
Phase
Phase 3
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

Who may be able to join

  • Inpatients with either acute leukemia patient receiving intensive chemotherapy or autologous transplantation for lymphoma, allogeneic stem cell transplantation

Who cannot join

  • ischemic heart failure
  • acute promyelocytic leukemia
  • ALKERAN autologous conditioning (myeloma patient)
  • disseminated intravascular coagulation
  • hemorrhagic syndrome
  • stroke
Show all 11Show fewer
  • any vital distress at diagnosis
  • creatinine clearance <50 ml/min
  • liver disease with ALT (alanine aminotransferase)/AST(aspartate aminotransferase) ≥2.5 ULN (upper limit of normal) (except if related to tumor)
  • pregnant female
  • autoimmune hemolytic anemia

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

  • University Hospital

    Caen, 14000

    Sylvain P Chantepie, MD, +33231272073, chantepie-s@chu-caen.fr

    Sylvain P Chantepie, MD

    Recruiting

Other trials in France

About this study

Official title: Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.

Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g / dL. These recommendations allow to transfuse a single RBP for very elderly patients or in cases of associated heart disease (heart failure). A recent development (2012) on post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk patients.

More recently, a Swiss team has historically compared transfusion policies in 2 139 patients with hematological malignancies. The first group received 2 RBP transfusion in case of symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP transfusion policy has resulted in a 25% decrease in the number of RBP used without any complication. In a prospective single-center pilot study, we showed that transfusing a single RBP was possible without increasing the side effects of anemia, without complications and allow an overall reduction in consumption of red blood cell units.

Read more

Several meta-analyzes reported in intensive care or bleeding situations that a restrictive use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and mortality. The number of patient to be treated to prevent one death is 33.

The main objective is to demonstrate in a randomized trial that the restrictive strategy (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are performed in case of hemoglobin level <8g/dL.

Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization with a comparison of complications/mortality in the 2 groups.

Being tested
Single red blood packed cells Transfusion, Two packed red blood cells Transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single red blood packed cells TransfusionDrug

  • Two packed red blood cells TransfusionDrug

Study groups in NCT02461264
Study groupRoleWhat they receive
ARM AActive comparatorTwo packed red blood cells will be transfused in patient with anemia defined as a hemoglobin level below 8 g / dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is <8 g / dL, two new packed red blood cells are transfused and so on.
Receives: Drug: Two packed red blood cells Transfusion
ARM BExperimentalSingle red blood packed cells Transfusion will be administered in patient with anemia defined as a hemoglobin level below 8 g/dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is <8 g / dL, a single unit is transfused and so on.
Receives: Drug: Single red blood packed cells Transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of severe complications (grade 3 or more)

    complications are defined as: stroke, transient ischemic attack, acute coronary syndrome, heart failure, arrhythmias or conduction cardiac disease, deep vein thrombosis, pulmonary embolism, elevated troponin, transfer to intensive care unit, death from any cause, new or progressive radiographic infiltrates, infections related to transfusion.

    Measured: up to 1 month after the last day of hospitalization

Secondary outcomes (9)

  1. number of RBP transfused

    Measured: up to 1 month after the last day of hospitalization

  2. Incidence of bleeding

    number of patient with bleeding grade 3 or more

    Measured: up to 1 month after the last day of hospitalization

  3. Transfusion related events

    Number of transfusion related events defined as any complication that the physician declared to be related to the transfusion (fever, infection, pulmonary edema..)

    Measured: up to 1 month after the last day of hospitalization

  4. Time to erythroid recovery

    Time from randomization to last transfusion

    Measured: up to 1 month after the last day of hospitalization

  5. Quality of life

    Functional Assessment of Cancer Therapy and QLC30

    Measured: up to 1 month after the last day of hospitalization

  6. time of aplasia

    from 1st day with neutrophils<500 to first day with neutrophils>500/mm3

    Measured: up to 1 month after the last day of hospitalization

  7. Transfusion performance

    difference between hemoglobin level before and 24 hours after transfusion

    Measured: up to 24 hours

  8. transfusion in out patient

    number of RBP transfused after leaving the unit

    Measured: up to 1 month after the last day of hospitalization

  9. Failure to respect the randomisation arm

    number of patient in arm B that received 2 RBP instead of single RBP

    Measured: up to 1 month after the last day of hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461264
Sponsor's protocol ID
14-128
Acronym
1VERSUS2CGR
Status last verified
Apr 2019
First submitted
28 May 2015
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. doi: 10.1111/j.1537-2995.2009.02518.x. Epub 2009 Dec 9.

    PubMed 20003061

  • Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14.

    PubMed 15486006

  • Wang JK, Klein HG. Red blood cell transfusion in the treatment and management of anaemia: the search for the elusive transfusion trigger. Vox Sang. 2010 Jan;98(1):2-11. doi: 10.1111/j.1423-0410.2009.01223.x. Epub 2009 Aug 4.

    PubMed 19682346

  • Ma M, Eckert K, Ralley F, Chin-Yee I. A retrospective study evaluating single-unit red blood cell transfusions in reducing allogeneic blood exposure. Transfus Med. 2005 Aug;15(4):307-12. doi: 10.1111/j.0958-7578.2005.00592.x.

    PubMed 16101808

  • Leal-Noval SR, Munoz-Gomez M, Jimenez-Sanchez M, Cayuela A, Leal-Romero M, Puppo-Moreno A, Enamorado J, Arellano-Orden V. Red blood cell transfusion in non-bleeding critically ill patients with moderate anemia: is there a benefit? Intensive Care Med. 2013 Mar;39(3):445-53. doi: 10.1007/s00134-012-2757-z. Epub 2012 Nov 27.

    PubMed 23184038

  • Watkins TC, Clark CT. Critically ill and septic patient: is red blood cell transfusion adding to the Domino Effect? J Infus Nurs. 2013 Mar-Apr;36(2):116-21. doi: 10.1097/NAN.0b013e318282a6cd.

    PubMed 23455973

  • Robitaille N, Lacroix J, Alexandrov L, Clayton L, Cortier M, Schultz KR, Bittencourt H, Duval M. Excess of veno-occlusive disease in a randomized clinical trial on a higher trigger for red blood cell transfusion after bone marrow transplantation: a canadian blood and marrow transplant group trial. Biol Blood Marrow Transplant. 2013 Mar;19(3):468-73. doi: 10.1016/j.bbmt.2012.12.002. Epub 2012 Dec 7.

    PubMed 23220014

  • Berger MD, Gerber B, Arn K, Senn O, Schanz U, Stussi G. Significant reduction of red blood cell transfusion requirements by changing from a double-unit to a single-unit transfusion policy in patients receiving intensive chemotherapy or stem cell transplantation. Haematologica. 2012 Jan;97(1):116-22. doi: 10.3324/haematol.2011.047035. Epub 2011 Sep 20.

    PubMed 21933858

  • Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.

    PubMed 22513904

  • Salpeter SR, Buckley JS, Chatterjee S. Impact of more restrictive blood transfusion strategies on clinical outcomes: a meta-analysis and systematic review. Am J Med. 2014 Feb;127(2):124-131.e3. doi: 10.1016/j.amjmed.2013.09.017. Epub 2013 Oct 7.

    PubMed 24331453

  • Mear JB, Chantepie SP, Gac AC, Bazin A and Reman O. A restrictive transfusion Strategy allow a reduction of the number of packed red blood cells: result of a pilot study; Abstract 2217; PH-AB153 Bone marrow Transplant 2014.

  • Chantepie SP, Mear JB, Briant AR, Vilque JP, Gac AC, Cheze S, Girault S, Turlure P, Marolleau JP, Lebon D, Charbonnier A, Jardin F, Lenain P, Peyro-Saint-Paul L, Abonnet V, Dutheil JJ, Chene Y, Bazin A, Reman O, Parienti JJ. Effect of single-unit transfusion in patients treated for haematological disease including acute leukemia: A multicenter randomized controlled clinical trial. Leuk Res. 2023 Jun;129:107058. doi: 10.1016/j.leukres.2023.107058. Epub 2023 Mar 18.

    PubMed 37080000

  • Chantepie SP, Mear JB, Guittet L, Dervaux B, Marolleau JP, Jardin F, Dutheil JJ, Parienti JJ, Vilque JP, Reman O. Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial. Trials. 2015 Nov 23;16:533. doi: 10.1186/s13063-015-1057-7.

    PubMed 26592377

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Single red blood packed cells Transfusion and Two packed red blood cells Transfusion in people with Transfusion Related Complication, run by University Hospital, Caen at 1 site in France.

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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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 France. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of severe complications (grade 3 or more) (time frame: up to 1 month after the last day of hospitalization). 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 NCT02461264, which also lists 13 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 22 Apr 2019.

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