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Trial record 13 of 296 for:    warfarin AND anticoagulation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483207
Recruitment Status : Unknown
Verified January 2018 by Dr. Hamada, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Hamada, Assiut University

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.

Condition or disease Intervention/treatment Phase
Mesenteric Vein Thrombosis Drug: Warfarin Procedure: MVT with failure of anticoagulation therapy Drug: Heparin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: MVT with anticoagulation therapy(heparin &warfarin)
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.
Drug: Warfarin
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 .

Procedure: MVT with failure of anticoagulation therapy
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.

Drug: Heparin
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 .

Experimental: MVT with failure of anticoagulation therapy(heparin &warfarin)
patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .
Drug: Warfarin
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 .

Procedure: MVT with failure of anticoagulation therapy
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.

Drug: Heparin
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 Measures :
  1. Anticoagulation therapy (heparin &warfarin) in MVO [ Time Frame: within 3-6 months of starting treatment. ]

    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 :
  1. Recurrence rate [ Time Frame: within six months of starting treatment. ]
    number of recurrent cases post conservative therapy .

  2. Mortality rate [ Time Frame: within one year of starting treatment. ]
    number of deaths as a complication of conservative therapy or surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483207


Contacts
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Contact: Hamada Fathy 01098010986 dr.hamada2139@gmail.com
Contact: faculty of medicine faculty of medicine- assuit university

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Dr. Hamada, Resident at General surgery department, Assiut University
ClinicalTrials.gov Identifier: NCT03483207    
Other Study ID Numbers: HF2018
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warfarin
Mesenteric Ischemia
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action