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NCT01906983 Clinical Trial

Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound

Thrombosis of Portal Venous System. Clinical Trial

Official title:
Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01906983
Other study ID # 0159-13-RMBCTIL
Secondary ID
Status Recruiting
Phase N/A
First received June 23, 2013
Last updated August 25, 2015
Start date July 2013

Study information
Verified date August 2015
Source Rambam Health Care Campus
Contact Hany Bahouth, M.D
Email h_bahouth@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Doppler Ultrasound
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.

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. pii: bcr1120092429. doi: 10.1136/bcr.11.2009.2429. — View Citation

Tran T, Demyttenaere SV, Polyhronopoulos G, Séguin 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Prior to discharge. No
Secondary 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. 3 months following injury. No