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

NCT01906983 | Unknown

• 1 other identifier: 0159-13-RMBCTIL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis of Portal Venous System.

Outcome Measures

Primary Outcomes (1)

• 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 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.

  3 months following injury.

Study Arms (1)

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

Interventions

Doppler Ultrasound OTHER

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.

Doppler ultrasound.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Trauma patients younger than 18.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

Related Publications (7)

• 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.

  PMID: 22767370 BACKGROUND

• 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.

  PMID: 12072606 BACKGROUND

• 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.

  PMID: 16565670 BACKGROUND

• 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.

  PMID: 19328396 BACKGROUND

• 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.

  PMID: 8729327 BACKGROUND

• 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.

  PMID: 8013799 BACKGROUND

• 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.

  PMID: 20039066 BACKGROUND

Study Officials

• Hany Bahouth, M.D

  Rambam Health Care Campus Haifa Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany Bahouth, M.D

CONTACT

h_bahouth@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

IL (1)