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

• Conditions: Thrombosis of Portal Venous System.
• Interventions: Other: Doppler Ultrasound

• Registration Number: NCT01906983
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-23
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-24
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Doppler ultrasound.	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel