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Completed

NCT Number: NCT03397732

Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury

The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
  • Over age 18
  • agree to participate

Exclusion criteria

  • under age 18
  • refuse to participate
  • diagnosed malignant disease
  • chronic steroid usage
  • being on cytostatic therapy

Treatment and study plan

aorto-bifemoral bypass and aorta stentgraft

Procedure

Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.

Primary outcomes

  1. Perioperative time course of the MMP-9-TIMP-1 system

    Time frame: 3 days

    To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.

Secondary outcomes

  1. MMP-9-TIMP-1 system and ischemia-reperfusion injury

    Time frame: 3 days

    To explore relationship between MMP-9-TIMP-1 system and vascular surgery related ischemia-reperfusion injury

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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