Mesenteric Vein ThrombosisNCT03483207
Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
A study testing Warfarin, MVT with failure of anticoagulation therapy and Heparin in people with Mesenteric Vein Thrombosis, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mesenteric Vein Thrombosis
- What is being tested?
- Warfarin, MVT with failure of anticoagulation therapy and Heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.
Trial locations and contacts
No sites are listed yet.
faculty of medicine faculty of medicine- assuit university contact
About this study
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.
Read the 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.
- Conditions
- Mesenteric Vein Thrombosis
- Being tested
- Warfarin, MVT with failure of anticoagulation therapy, Heparin
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
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 .
MVT with failure of anticoagulation therapyProcedure or surgery
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.
HeparinDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| MVT with anticoagulation therapy(heparin &warfarin) | Experimental | 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. Receives: Drug: Warfarin; Procedure: MVT with failure of anticoagulation therapy; Drug: Heparin |
| MVT with failure of anticoagulation therapy(heparin &warfarin) | Experimental | patients who underwent conservative therapy with anticoagulation (heparin \&warfarin) but showed no improvement . Receives: Drug: Warfarin; Procedure: MVT with failure of anticoagulation therapy; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3-6 months of starting treatment.
Secondary outcomes (2)
Recurrence rate
number of recurrent cases post conservative therapy .
Measured: within six months of starting treatment.
Mortality rate
number of deaths as a complication of conservative therapy or surgery
Measured: within one year of starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mesenteric Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hamada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483207
- Sponsor's protocol ID
- HF2018
- Status last verified
- Jan 2018
- First submitted
- 20 Jan 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grendell JH, Ockner RK. Mesenteric venous thrombosis. Gastroenterology. 1982 Feb;82(2):358-72. No abstract available.
PubMed 7033036Zhang 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.
PubMed 15288639Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med. 2010 Oct;15(5):407-18. doi: 10.1177/1358863X10379673.
PubMed 20926500Harward TR, Green D, Bergan JJ, Rizzo RJ, Yao JS. Mesenteric venous thrombosis. J Vasc Surg. 1989 Feb;9(2):328-33.
PubMed 2918628Prout 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.
PubMed 5427470Rhee 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.
PubMed 7966803Kumar 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.
PubMed 12818273Pabinger 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.
PubMed 8640401Brunaud 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.
PubMed 11668323
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
- ClinicalTrials.gov ID
- NCT03483207
- Acronym / sponsor ID
- HF2018
- Conditions
- Mesenteric Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MVT with anticoagulation therapy(heparin &warfarin) | Experimental | Drug: Warfarin, Procedure: MVT with failure of anticoagulation therapy, Drug: Heparinpatients 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. |
| MVT with failure of anticoagulation therapy(heparin &warfarin) | Experimental | Drug: Warfarin, Procedure: MVT with failure of anticoagulation therapy, Drug: Heparinpatients who underwent conservative therapy with anticoagulation (heparin \&warfarin) but showed no improvement . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinPatients 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 . | Drug | MVT with anticoagulation therapy(heparin &warfarin), MVT with failure of anticoagulation therapy(heparin &warfarin) |
| MVT with failure of anticoagulation therapypatients 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. | Procedure or surgery | MVT with anticoagulation therapy(heparin &warfarin), MVT with failure of anticoagulation therapy(heparin &warfarin) |
| HeparinPatients 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 . | Drug | MVT with anticoagulation therapy(heparin &warfarin), MVT with failure of anticoagulation therapy(heparin &warfarin) |
Primary outcome
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
2 secondary outcomes
Recurrence rate
Time frame: within six months of starting treatment.
Mortality rate
Time frame: within one year of starting treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 7033036Grendell JH, Ockner RK. Mesenteric venous thrombosis. Gastroenterology. 1982 Feb;82(2):358-72. No abstract available.
- Background: PubMed 15288639Zhang 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.
- Background: PubMed 20926500Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med. 2010 Oct;15(5):407-18. doi: 10.1177/1358863X10379673.
- Background: PubMed 2918628Harward TR, Green D, Bergan JJ, Rizzo RJ, Yao JS. Mesenteric venous thrombosis. J Vasc Surg. 1989 Feb;9(2):328-33.
- Background: PubMed 5427470Prout 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.
- Background: PubMed 7966803Rhee 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.
- Background: PubMed 12818273Kumar 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.
- Background: PubMed 8640401Pabinger 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.
- Background: PubMed 11668323Brunaud 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.
- Individual participant dataSharing planned: No
Related trials for Mesenteric Vein Thrombosis
Not yet recruiting
Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort
Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
faculty of medicine faculty of medicine- assuit university contact
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin, MVT with failure of anticoagulation therapy and Heparin in people with Mesenteric Vein Thrombosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamada Fathy (01098010986, dr.hamada2139@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticoagulation therapy (heparin &warfarin) in MVO (time frame: within 3-6 months of starting treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483207, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.