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

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 Overview

• Status: Unknown
• Conditions: Thrombosis of Portal Venous System.
• Intervention / Treatment: Other: Doppler Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Hany Bahouth, M.D; Email: h_bahouth@rambam.health.gov.il
    • Principal Investigator: Hany Bahouth, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Hany Bahouth, M.D, Rambam Health Care Campus Haifa Israel

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: June 23, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 0159-13-RMBCTIL