Thrombosis of Portal Venous System.NCT01906983
Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound
An observational study of Thrombosis of Portal Venous System., run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The true incidence of thrombosis in the portal venous system after blunt splenic trauma is unknown and has not been elucidated in the medical literature. The investigators hypothesize that this entity is more common than previously suspected. Consequences of missing this diagnosis can be clinically significant, i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis of Portal Venous System.
- What is being tested?
- Doppler Ultrasound
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Aug 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.
Who may be able to join
- All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.
Who cannot join
- Trauma patients younger than 18.
Trial locations and contacts
1 site in 1 country.
Hany Bahouth, M.D contact
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Hany Bahouth, M.D, h_bahouth@rambam.health.gov.il
Hany Bahouth, M.D
About this study
The true incidence of thrombosis in the portal venous system after blunt splenic trauma is unknown and has not been elucidated in the medical literature. The investigators hypothesize that this entity is more common than previously suspected. Consequences of missing this diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment with anticoagulation and avoidance of these complications. In a prospective fashion, doppler ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up who have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in patients initially diagnosed with thrombosis in the portal venous system on their 3 month ultrasound. The investigators will attempt to identify risk factors in this trauma population that would facilitate an early screening protocol.
- Conditions
- Thrombosis of Portal Venous System.
- Being tested
- Doppler Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler UltrasoundOther
Doppler ultrasound will be performed to patients with blunt splenic trauma, prior to discharge and again, at 3-6 months in patients with thrombosis indication.
| Study group | Role | What they receive |
|---|---|---|
| Doppler ultrasound. | Doppler ultrasound will be performed to All patients 18 and up, admitted to Rambam Medical Center with diagnosis of blunt splenic trauma and agree to participate the study. Receives: Other: Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilizing doppler ultrasound to assess the presence of partial or complete thrombosis in the portal venous system (splenic vein, superior mesenteric vein, inferior mesenteric vein and/or portal vein) after blunt splenic trauma.
Measured: Prior to discharge.
Secondary outcomes (1)
Utilizing follow-up doppler ultrasound to assess change in the presence of partial or complete thrombosis in the portal venous system (splenic vein, superior mesenteric vein, inferior mesenteric vein and/or portal vein) after blunt splenic trauma.
Measured: 3 months following injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thrombosis of Portal Venous System.Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany Bahouth, M.D, Principal investigator, Rambam Health Care Campus Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906983
- Sponsor's protocol ID
- 0159-13-RMBCTIL
- Status last verified
- Aug 2015
- First submitted
- 23 Jun 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rajkomar V, Kyerematen E, Mysore P, Penston J. Thrombosis of the portal venous system following blunt abdominal trauma. BMJ Case Rep. 2010 Aug 24;2010:bcr1120092429. doi: 10.1136/bcr.11.2009.2429.
PubMed 22767370Fried M, Van Ganse W, Van Avermaet S. Mesenteric vein thrombosis triggered by blunt abdominal trauma in a patient with the primary antiphospholipid syndrome. Eur J Gastroenterol Hepatol. 2002 Jun;14(6):697-700. doi: 10.1097/00042737-200206000-00017.
PubMed 12072606Gonzalez F, Condat B, Deltenre P, Mathurin P, Paris JC, Dharancy S. Extensive portal vein thrombosis related to abdominal trauma. Gastroenterol Clin Biol. 2006 Feb;30(2):314-6. doi: 10.1016/s0399-8320(06)73173-6.
PubMed 16565670Gopal SV, Smith I, Malka V. Acute portal venous thrombosis after blunt abdominal trauma. Am J Emerg Med. 2009 Mar;27(3):372.e1-372.e3. doi: 10.1016/j.ajem.2008.07.021. No abstract available.
PubMed 19328396Beaufort P, Perney P, Coste F, Masbou J, Le Bricquir Y, Blanc F. [Post-traumatic thrombosis of the portal vein]. Presse Med. 1996 Feb 17;25(6):247-8. French.
PubMed 8729327Duvoux C, Radier C, Gouault-Heilmann M, Texier JP, Le Cudonnec B, Dhumeaux D. [A rare cause of portal vein thrombosis: closed abdominal trauma]. Gastroenterol Clin Biol. 1994;18(2):165-7. French.
PubMed 8013799Tran T, Demyttenaere SV, Polyhronopoulos G, Seguin C, Artho GP, Kaneva P, Fried GM, Feldman LS. Recommended timing for surveillance ultrasonography to diagnose portal splenic vein thrombosis after laparoscopic splenectomy. Surg Endosc. 2010 Jul;24(7):1670-8. doi: 10.1007/s00464-009-0828-1. Epub 2009 Dec 29.
PubMed 20039066
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound
- ClinicalTrials.gov ID
- NCT01906983
- Acronym / sponsor ID
- 0159-13-RMBCTIL
- Conditions
- Thrombosis of Portal Venous System.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- 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.
The true incidence of thrombosis in the portal venous system after blunt splenic trauma is unknown and has not been elucidated in the medical literature. The investigators hypothesize that this entity is more common than previously suspected. Consequences of missing this diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment with anticoagulation and avoidance of these complications. In a prospective fashion, doppler ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up who have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in patients initially diagnosed with thrombosis in the portal venous system on their 3 month ultrasound. The investigators will attempt to identify risk factors in this trauma population that would facilitate an early screening protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doppler ultrasound. | – | Other: Doppler UltrasoundDoppler ultrasound will be performed to All patients 18 and up, admitted to Rambam Medical Center with diagnosis of blunt splenic trauma and agree to participate the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.
Key inclusion criteria (1 listed)
- All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.
Key exclusion criteria (1 listed)
- Trauma patients younger than 18.
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 |
|---|---|---|
| Doppler UltrasoundDoppler ultrasound will be performed to patients with blunt splenic trauma, prior to discharge and again, at 3-6 months in patients with thrombosis indication. | Other | Doppler ultrasound. |
Primary outcome
Utilizing doppler ultrasound to assess the presence of partial or complete thrombosis in the portal venous system (splenic vein, superior mesenteric vein, inferior mesenteric vein and/or portal vein) after blunt splenic trauma.
Time frame: Prior to discharge.
1 secondary outcome
Utilizing follow-up doppler ultrasound to assess change in the presence of partial or complete thrombosis in the portal venous system (splenic vein, superior mesenteric vein, inferior mesenteric vein and/or portal vein) after blunt splenic trauma.
Time frame: 3 months following injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 22767370Rajkomar V, Kyerematen E, Mysore P, Penston J. Thrombosis of the portal venous system following blunt abdominal trauma. BMJ Case Rep. 2010 Aug 24;2010:bcr1120092429. doi: 10.1136/bcr.11.2009.2429.
- Background: PubMed 12072606Fried M, Van Ganse W, Van Avermaet S. Mesenteric vein thrombosis triggered by blunt abdominal trauma in a patient with the primary antiphospholipid syndrome. Eur J Gastroenterol Hepatol. 2002 Jun;14(6):697-700. doi: 10.1097/00042737-200206000-00017.
- Background: PubMed 16565670Gonzalez F, Condat B, Deltenre P, Mathurin P, Paris JC, Dharancy S. Extensive portal vein thrombosis related to abdominal trauma. Gastroenterol Clin Biol. 2006 Feb;30(2):314-6. doi: 10.1016/s0399-8320(06)73173-6.
- Background: PubMed 19328396Gopal SV, Smith I, Malka V. Acute portal venous thrombosis after blunt abdominal trauma. Am J Emerg Med. 2009 Mar;27(3):372.e1-372.e3. doi: 10.1016/j.ajem.2008.07.021. No abstract available.
- Background: PubMed 8729327Beaufort P, Perney P, Coste F, Masbou J, Le Bricquir Y, Blanc F. [Post-traumatic thrombosis of the portal vein]. Presse Med. 1996 Feb 17;25(6):247-8. French.
- Background: PubMed 8013799Duvoux C, Radier C, Gouault-Heilmann M, Texier JP, Le Cudonnec B, Dhumeaux D. [A rare cause of portal vein thrombosis: closed abdominal trauma]. Gastroenterol Clin Biol. 1994;18(2):165-7. French.
- Background: PubMed 20039066Tran T, Demyttenaere SV, Polyhronopoulos G, Seguin C, Artho GP, Kaneva P, Fried GM, Feldman LS. Recommended timing for surveillance ultrasonography to diagnose portal splenic vein thrombosis after laparoscopic splenectomy. Surg Endosc. 2010 Jul;24(7):1670-8. doi: 10.1007/s00464-009-0828-1. Epub 2009 Dec 29.
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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.
Hany Bahouth, M.D contact
Hany Bahouth, M.D principal investigator
Rambam Health Care Campus Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis of Portal Venous System., run by Rambam Health Care Campus at 1 site in Israel.
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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hany Bahouth, M.D (h_bahouth@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilizing doppler ultrasound to assess the presence of partial or complete thrombosis in the portal venous system (splenic vein, superior mesenteric vein, inferior mesenteric vein and/or portal vein) after blunt splenic trauma. (time frame: Prior to discharge.). 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 NCT01906983, which also lists 7 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 26 Aug 2015.