Evidence map›Paper›PMID 31186035›Full record

ArticleTrials2019

Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized clinical trial.

Mauro Panigada, Elena Spinelli, Alberto Cucino, Elisa Cipriani, Stefano De Falco, Giovanna Panarello, Giovanna Occhipinti, Antonio Arcadipane, Gabriele Sales, Vito Fanelli and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03208270 (Pilot Study of Antithrombin Supplementation During Extracorporeal Membrane Oxigenation), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03208270 phase2 / phase3completednot on this map

Pilot Study of Antithrombin Supplementation During Extracorporeal Membrane Oxigenation

TypeinterventionalSponsorPoliclinico HospitalRan2017 to 2019Enrolled49ConditionsExtracorporeal Membrane OxygenationArmsAntithrombin supplementation, No antithrombin supplementation
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
  4. Review
  5. Article
  6. Anticoagulation in ECMO patients: an overview.Indian journal of thoracic and cardiovascular surgery · 2021
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Mauro PanigadaDepartment of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. mauro.panigada@outlook.com.ORCID http://orcid.org/0000-0003-4841-9794
Elena SpinelliDepartment of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Alberto CucinoDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Elisa CiprianiDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Stefano De FalcoDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Giovanna PanarelloDepartment of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.
Giovanna OcchipintiDepartment of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.
Antonio ArcadipaneDepartment of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.
Gabriele SalesDepartment of Surgical Sciences, University of Turin, Turin, Italy.
Vito FanelliDepartment of Surgical Sciences, University of Turin, Turin, Italy.
Luca BrazziDepartment of Surgical Sciences, University of Turin, Turin, Italy.
Cristina NovembrinoClinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Dario ConsonniEpidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Antonio PesentiDepartment of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Giacomo GrasselliDepartment of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
University of Milan · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione · ITUniversity of Turin · IT

Funding

GRIFOLS 153_2016
6 · The paper itself

Abstract

backgroundNormal levels of plasma antithrombin (AT) activity might decrease heparin requirements to achieve an adequate level of anticoagulation during treatment with extracorporeal membrane oxygenation (ECMO). Acquired AT deficiency during ECMO is common, but formal recommendations on target, timing, and rate of AT supplementation are lacking. Thus, we conceived a pilot trial to evaluate the feasibility and safety of prolonged AT supplementation in patients requiring veno-venous ECMO for respiratory failure.

methodsGrifols Antithrombin Research Awards (GATRA) is a prospective, randomized, single blinded, multicenter, controlled two-arm trial. Patients undergoing veno-venous ECMO will be randomized to either receive AT supplementation to maintain a functional AT level between 80 and 120% (AT supplementation group) or not (control group) for the entire ECMO course. In both study groups, anticoagulation will be provided with unfractionated heparin following a standardized protocol. The primary endpoint will be the dose of heparin required to maintain the ratio of activated partial thromboplastin time between 1.5 and 2. Secondary endpoints will be the adequacy of anticoagulation and the incidence of hemorrhagic and thrombotic complications. DISCUSSION: GATRA is a pilot trial that will test the efficacy of a protocol of AT supplementation in decreasing the heparin dose and improving anticoagulation adequacy during ECMO. If positive, it might provide the basis for a future larger trial aimed at verifying the impact of AT supplementation on a composite outcome endpoint including hemorrhagic events, transfusion requirements, and mortality.

trial registrationClinicalTrials.gov, NCT03208270 . Registered on 5 July 2017.

Indexed as

Randomized Controlled Trials as TopicAdultAntithrombinsDietary SupplementsExtracorporeal Membrane OxygenationHumansPilot ProjectsProspective StudiesRespiratory InsufficiencySingle-Blind MethodAntithrombins

Identifiers

PMID31186035
PMCPMC6558738
OpenAlexW2952679754

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.