search
Back to results

Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies

Primary Purpose

Mesenteric Vein Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Warfarin
MVT with failure of anticoagulation therapy
Heparin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenteric Vein Thrombosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients admitted in the department of surgery in Assiut University diagnosed to have mesenteric venous occlusion not presented by signs of peritonitis or confirmed radiological signs of bowel infarction.

Exclusion Criteria:

1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    MVT with anticoagulation therapy(heparin &warfarin)

    MVT with failure of anticoagulation therapy(heparin &warfarin)

    Arm Description

    patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively with anticoagulation(heparin &warfarin) while other cases will be for surgical management and not included in the study.

    patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .

    Outcomes

    Primary Outcome Measures

    Anticoagulation therapy (heparin &warfarin) in MVO
    patients with confirmed diagnosis of acute MVT on CT scan will be treated conservatively In addition to usual care such as fluid and electrolyte balance, antibiotic coverage and nasogastric intubation ,intravenous heparin will be started and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. All patients will be critically followed up(Clinically.. Radiologically ) for the progress of response of therapy , failure to improve or worsening in condition( appearance of signs of peritonitis such as guarding, rigidity and fever...or radiological signs of bowel infarction) will be assessed . Factors that may affect the response such as ( age, duration from onset of the disease till starting therapy,underlying diseases,.. )also complications (hemorrhage, failure ,..)will be assessed

    Secondary Outcome Measures

    Recurrence rate
    number of recurrent cases post conservative therapy .
    Mortality rate
    number of deaths as a complication of conservative therapy or surgery

    Full Information

    First Posted
    January 20, 2018
    Last Updated
    March 29, 2018
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03483207
    Brief Title
    Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
    Official Title
    Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Initial treatment in the management of acute mesenteric vein thrombosis (MVT) is controversial. Some authors have proposed a surgical approach, whereas others have advocated medical therapy (anticoagulation). In this study, the investigators analyzed and compared the results obtained with surgical and medical treatment to determine the best initial management for this disease.
    Detailed Description
    Mesenteric venous thrombosis (MVT) is increasingly recognized as a cause of mesenteric ischemia. it must be distinguished from arterial and non occlusive types of ischemia, it accounts for 5% to 15% of all cases of mesenteric ischemia. Patients may have evocative signs,such as abdominal pain that is out of proportion to physical signs, nausea, or vomiting. However, a clinical diagnosis is often difficult because abdominal symptoms are non specific and high index of suspicion is often required for diagnosis.(1) Primary MVT accounted for 25% to 55% of cases in early studies, but recent reports show decline in primary MVT because of improvements in the diagnosis of hypercoagulable states.(2) Advances in new imaging techniques also have enabled early recognition of this disease without or before laparotomy.(3-5 ) Fortunately , there is no consensus about the initial management of MVT; Some authors have proposed an aggressive surgical approach (6) while others have advocated an initial conservative management with anticoagulation and close monitoring . ( 7) similarly,issue of second look laparotomy,mandatory or selective is yet not resolved. The present study is prompted to analyze our experience in an effort to resolve these controversies and the results obtained will be assessed to determine the best management strategy for this uncommon disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mesenteric Vein Thrombosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Diagnosis of acute MVT will be based on clinical presentation &positive CT scan.(9) .patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively .(11)In addition to usual care ,intravenous heparin will be started and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. (12) followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. All patients will be critically monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then" second look" laparotomy will be perfomed .The mortality and all complications associated with surgery will be recorded.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MVT with anticoagulation therapy(heparin &warfarin)
    Arm Type
    Experimental
    Arm Description
    patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively with anticoagulation(heparin &warfarin) while other cases will be for surgical management and not included in the study.
    Arm Title
    MVT with failure of anticoagulation therapy(heparin &warfarin)
    Arm Type
    Experimental
    Arm Description
    patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .
    Intervention Type
    Drug
    Intervention Name(s)
    Warfarin
    Intervention Description
    Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. patients will be critically monitored for the progress of response of therapy .
    Intervention Type
    Procedure
    Intervention Name(s)
    MVT with failure of anticoagulation therapy
    Intervention Description
    patients managed conservatively with anticoagulation will be monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then" second look" laparotomy will be performed .The mortality and all complications associated with surgery will be recorded.
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin
    Intervention Description
    Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. patients will be critically monitored for the progress of response of therapy .
    Primary Outcome Measure Information:
    Title
    Anticoagulation therapy (heparin &warfarin) in MVO
    Description
    patients with confirmed diagnosis of acute MVT on CT scan will be treated conservatively In addition to usual care such as fluid and electrolyte balance, antibiotic coverage and nasogastric intubation ,intravenous heparin will be started and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. All patients will be critically followed up(Clinically.. Radiologically ) for the progress of response of therapy , failure to improve or worsening in condition( appearance of signs of peritonitis such as guarding, rigidity and fever...or radiological signs of bowel infarction) will be assessed . Factors that may affect the response such as ( age, duration from onset of the disease till starting therapy,underlying diseases,.. )also complications (hemorrhage, failure ,..)will be assessed
    Time Frame
    within 3-6 months of starting treatment.
    Secondary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    number of recurrent cases post conservative therapy .
    Time Frame
    within six months of starting treatment.
    Title
    Mortality rate
    Description
    number of deaths as a complication of conservative therapy or surgery
    Time Frame
    within one year of starting treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Patients admitted in the department of surgery in Assiut University diagnosed to have mesenteric venous occlusion not presented by signs of peritonitis or confirmed radiological signs of bowel infarction. Exclusion Criteria: 1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamada Fathy
    Phone
    01098010986
    Email
    dr.hamada2139@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    faculty of medicine faculty of medicine- assuit university

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7033036
    Citation
    Grendell JH, Ockner RK. Mesenteric venous thrombosis. Gastroenterology. 1982 Feb;82(2):358-72. No abstract available.
    Results Reference
    background
    PubMed Identifier
    15288639
    Citation
    Zhang J, Duan ZQ, Song QB, Luo YW, Xin SJ, Zhang Q. Acute mesenteric venous thrombosis: a better outcome achieved through improved imaging techniques and a changed policy of clinical management. Eur J Vasc Endovasc Surg. 2004 Sep;28(3):329-34. doi: 10.1016/j.ejvs.2004.06.001.
    Results Reference
    background
    PubMed Identifier
    20926500
    Citation
    Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med. 2010 Oct;15(5):407-18. doi: 10.1177/1358863X10379673.
    Results Reference
    background
    PubMed Identifier
    2918628
    Citation
    Harward TR, Green D, Bergan JJ, Rizzo RJ, Yao JS. Mesenteric venous thrombosis. J Vasc Surg. 1989 Feb;9(2):328-33.
    Results Reference
    background
    PubMed Identifier
    5427470
    Citation
    Prout WG. The significance of rebound tenderness in the acute abdomen. Br J Surg. 1970 Jul;57(7):508-10. doi: 10.1002/bjs.1800570706. No abstract available.
    Results Reference
    background
    PubMed Identifier
    7966803
    Citation
    Rhee RY, Gloviczki P, Mendonca CT, Petterson TM, Serry RD, Sarr MG, Johnson CM, Bower TC, Hallett JW Jr, Cherry KJ Jr. Mesenteric venous thrombosis: still a lethal disease in the 1990s. J Vasc Surg. 1994 Nov;20(5):688-97. doi: 10.1016/s0741-5214(94)70155-5.
    Results Reference
    background
    PubMed Identifier
    12818273
    Citation
    Kumar S, Kamath PS. Acute superior mesenteric venous thrombosis: one disease or two? Am J Gastroenterol. 2003 Jun;98(6):1299-304. doi: 10.1111/j.1572-0241.2003.07338.x.
    Results Reference
    background
    PubMed Identifier
    8640401
    Citation
    Pabinger I, Schneider B. Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose- und Hamostaseforschung (GTH) Study Group on Natural Inhibitors. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):742-8. doi: 10.1161/01.atv.16.6.742.
    Results Reference
    background
    PubMed Identifier
    11668323
    Citation
    Brunaud L, Antunes L, Collinet-Adler S, Marchal F, Ayav A, Bresler L, Boissel P. Acute mesenteric venous thrombosis: case for nonoperative management. J Vasc Surg. 2001 Oct;34(4):673-9. doi: 10.1067/mva.2001.117331.
    Results Reference
    background

    Learn more about this trial

    Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies

    We'll reach out to this number within 24 hrs