- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483207
Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hamada Fathy
- Phone Number: 01098010986
- Email: dr.hamada2139@gmail.com
Study Contact Backup
- Name: faculty of medicine faculty of medicine- assuit university
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 .
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.
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 .
|
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 .
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.
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
within 3-6 months of starting treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate
Time Frame: within six months of starting treatment.
|
number of recurrent cases post conservative therapy .
|
within six months of starting treatment.
|
Mortality rate
Time Frame: within one year of starting treatment.
|
number of deaths as a complication of conservative therapy or surgery
|
within one year of starting treatment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Grendell JH, Ockner RK. Mesenteric venous thrombosis. Gastroenterology. 1982 Feb;82(2):358-72. No abstract available.
- 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.
- Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med. 2010 Oct;15(5):407-18. doi: 10.1177/1358863X10379673.
- Harward TR, Green D, Bergan JJ, Rizzo RJ, Yao JS. Mesenteric venous thrombosis. J Vasc Surg. 1989 Feb;9(2):328-33.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Peritoneal Diseases
- Gastrointestinal Diseases
- Embolism and Thrombosis
- Intestinal Diseases
- Thrombosis
- Venous Thrombosis
- Mesenteric Ischemia
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Warfarin
Other Study ID Numbers
- HF2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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