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Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis. (ABAS)

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ClinicalTrials.gov Identifier: NCT04402775
Recruitment Status : Terminated (Due to a low inclusion rate)
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
M.J.C. de Kok, HagaZiekenhuis

Brief Summary:
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Tourniquet Stenosis Other: Tourniquet Not Applicable

Detailed Description:

Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.

Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
Study Start Date : April 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
No Intervention: Vascular clamps
Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
Experimental: Tourniquet
Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
Other: Tourniquet
A tourniquet will be used during surgery




Primary Outcome Measures :
  1. Stenosis postoperative (duplex ultrasonography) [ Time Frame: 6 weeks ]
    Luminal vessel diameter


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: During surgery ]
    Duration of surgery in minutes

  2. AVF occlusion [ Time Frame: Within 3 months after surgery ]
    AVF occlusion

  3. Bleeding [ Time Frame: Within 3 months after surgery ]
    Bleeding

  4. Infection [ Time Frame: Within 3 months after surgery ]
    Infection

  5. Pseudoaneurysm [ Time Frame: Within 3 months after surgery ]
    Pseudoaneurysm

  6. Need for reintervention [ Time Frame: 1 year postoperative ]
    Surgical or endovascular reintervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mentally competent
  • Written informed consent
  • Age 18 years and older
  • Indication for brachiocephalic AVF in HagaZiekenhuis
  • Patient is able to complete the follow-up evaluation

Exclusion Criteria:

  • Pregnancy
Publications:
Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.

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Responsible Party: M.J.C. de Kok, Medical student, HagaZiekenhuis
ClinicalTrials.gov Identifier: NCT04402775    
Other Study ID Numbers: NL54827.098.15
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Arteriovenous Fistula
Constriction, Pathologic
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities