Clinical trial NCT01906983: Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound
Official title: Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis of Portal Venous System.
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.

Exclusion Criteria:

* Trauma patients younger than 18.

Primary outcomes:
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.
timeFrame: Prior to discharge.
Secondary outcomes:
measure: 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.
timeFrame: 3 months following injury.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus Haifa Israel
name: Hany Bahouth, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fried 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.
citation: Gonzalez 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.
citation: Gopal 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.
citation: Beaufort 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.
citation: Duvoux 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.
citation: Tran 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.