NCT03006120

Brief Summary

Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

6.9 years

First QC Date

December 28, 2016

Last Update Submit

December 30, 2016

Conditions

Treatment ProcedureMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality

    01/01/2010- 31/10/2016

Study Arms (3)

Group 1

Conservative management

Procedure: Retroperitoneal hematoma due to cardiac catheterization

Group 2

Angiografic stenting

Procedure: Retroperitoneal hematoma due to cardiac catheterization

Group 3

Surgery

Procedure: Retroperitoneal hematoma due to cardiac catheterization

Interventions

Retroperitoneal hematoma due to cardiac catheterizationPROCEDURE
Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retroperitoneal hematoma following cardiac catheterization in our institution between January 2010 and October 2016.

You may qualify if:

  • Retroperitoneal hematoma following cardiac catheterization

You may not qualify if:

  • Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Depertmant of Gastroenterological Surgery, Principal Investigator, Clinical M.D

Study Record Dates

First Submitted

December 28, 2016

First Posted

December 30, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12