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Alterations of Blood Clotting With the Use of Sequential Compression Devices on the Lower Limbs (TEGLeg)

4. november 2013 opdateret af: Guido Fanelli, University of Parma

Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery

This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.

The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.

In addition to common laboratory tests, the investigators will examine coagulation using TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Low molecular weight heparins (LMWH) are routinely used in perioperative prophylaxis of thromboembolic complications [(chiefly deep vein thrombosis (DVT)]. LMWHs have been proved to be safe and equipotent or superior when compared with unfractionated heparin.

Sequential compressing devices (SCD) are relatively novel pneumatic stockings with several air chambers. A computerized pump applies a gradient of pressure which decreases from the foot cranially. Pressure is also applied intermittently according to predetermined schedules. This devices are being employed for DVT prophylaxis in patients for whom anticoagulation therapy is contraindicated, or in those who have a low risk of DVT. They have also been employed to complement anticoagulant therapy in patients at high risk of DVT, such as those undergoing orthopedic surgery (Fordyce, 1992; Handoll, 2002; Warwick, 2002; Pitto, 2004).

The mechanism of action of SCD seems to be primarily mechanical, through a displacement of a column of blood through the venous system and towards the heart; they act as a surrogate of the muscular pump in immobilized patients (Killewich, 1995).

There is also some evidence that SCD activity may influence the coagulation/fibrinolysis system towards hypocoagulability (Dai, 2000; Kohro, 2003); Kohro and colleagues have also hypothesized that the shear forces generated by SCD may alter platelet adhesion by a direct effect on platelets and/or by increasing the release of factors from the venous endothelium (Kohro, 2005).

The investigators aim to assess the effects on coagulation when SCD are applied to patients at high risk of DVT in addition to standard LMWH therapy.The investigators chose to study a population in whom SCD may be useful in reducing the incidence of DVT, such as patients undergoing postoperative monitoring in the intensive care unit (ICU) after major abdominal surgery for cancer.

In addition to standard laboratory tests, the investigators will use thrombelastography (TEG®) to assess all phases of coagulation. A TEG parameter, maximum amplitude (MA), has been linked to an increase of thrombotic complications in a postoperative population (McCrath, 2005).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • PR
      • Parma, PR, Italien, 43100
        • University Hospital / Azienda Ospedaliero-Universitaria

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Elective major abdominal surgery for neoplasm

  • Planned admission to postsurgical ICU due to the patient's meeting one or more of the following:

    • ASA Physical Status Class 4
    • Surgery of modified Johns-Hopkins class ≥IV
    • ASA 3 with modified Johns-Hopkins class 3 surgery
    • Expected duration of surgery ≥8 h

Exclusion Criteria:

  • History of coagulation abnormalities, either congenital or acquired
  • Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones
  • Massive edema of the legs
  • Severe peripheral arteriopathy or neuropathy
  • Malformations or recent surgery/trauma to the lower extremities

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SCD + LMWH
This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.
Enhed: Sequential compression device therapy

Pneumatic stockings will be applied to patients.

Pressures ranging from 12 to 40 mmHg will be applied at different levels of the lower limb for 40-second cycles at 2-minute intervals. Therapy will continue until the morning after surgery.

Andre navne:
  • SCD EXPRESS
  • Foot pump
Medicin: Dalteparin
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
Andre navne:
  • lavmolekylært heparin
  • heparin
  • antikoagulant
  • LMWH
  • Fragmin
  • tromboprofylakse
Procedure: TEG

A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.

TEG analyses will be run at:

  • Patient admission (before SCD start)
  • 40-60 min after admission
  • Morning after surgery
Andre navne:
  • thrombelastography
  • TEG®
  • thrombelastogram
Aktiv komparator: LMWH only
Patients in this group will receive only standard LMWH therapy during their ICU stay.
Medicin: Dalteparin
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
Andre navne:
  • lavmolekylært heparin
  • heparin
  • antikoagulant
  • LMWH
  • Fragmin
  • tromboprofylakse
Procedure: TEG

A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.

TEG analyses will be run at:

  • Patient admission (before SCD start)
  • 40-60 min after admission
  • Morning after surgery
Andre navne:
  • thrombelastography
  • TEG®
  • thrombelastogram

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time
Tidsramme: 24 hours from application of SCD
24 hours from application of SCD

Sekundære resultatmål

Resultatmål
Tidsramme
Reduction in the area under the curve of the r time TEG value over time
Tidsramme: 24 h after application of SCD
24 h after application of SCD
Reduction in the area under the curve of the alpha angle TEG value over time
Tidsramme: 24 h after application of SCD
24 h after application of SCD
Incidence of hypotension (mean arterial pressure ≤60 mmHg)
Tidsramme: ≤24 h after application of SCD
≤24 h after application of SCD

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Parma

Efterforskere

  • Studiestol: Guido Fanelli, MD, University of Parma
  • Ledende efterforsker: Maria Barbagallo, MD, UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

29. juli 2008

Først indsendt, der opfyldte QC-kriterier

31. juli 2008

Først opslået (Skøn)

1. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICU-ICU-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperative komplikationer

Kliniske forsøg med Sequential compression device therapy

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