Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608591
Status:
UNKNOWN
Last Update Posted:
2020-10-29
First Post:
2020-10-19
Brief Title:
A Prospective Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries
Sponsor:
University of Limerick
Organization:
University of Limerick
Study Overview
Official Title:
A Prospective Multicentre Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries RRequiring Immobilisation to Identify High Risk Patients Requiring Thromboprophylaxis
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TILLIRI
Brief Summary:
This study is aimed at identifying patients at high risk for Venous Thrombo-Embolism VTE clots in the veins of legs or clots in the lungs who have lower limb injuries treated with immobilisation of the lower limb The study aims to identify high risk patients who may benefit from thromboprophylaxis blood thinning medication to prevent such clots forming
To do this we will collect data on 3500 patients who present with lower limb injury requiring immobilisation to the Emergency Departments of the six hospitals named
We will assess their risk factors for venous thrombosis at the time of presentation and contact them at twelve weeks to assess if they have had a VTE in order to develop a risk scoring system which can be used to predict the likelihood of VTE development
This risk scoring system can then be used to identify high risk patients who may benefit from thromboprophylaxis
To do this we will collect data on 3500 patients who present with lower limb injury requiring immobilisation to the Emergency Departments of the six hospitals named
We will assess their risk factors for venous thrombosis at the time of presentation and contact them at twelve weeks to assess if they have had a VTE in order to develop a risk scoring system which can be used to predict the likelihood of VTE development
This risk scoring system can then be used to identify high risk patients who may benefit from thromboprophylaxis
Detailed Description:
Currently there is wide variation in the provision of venous thromboembolism VTE prophylaxis for patients who suffer lower limb trauma and require lower limb immobilisation Current United Kingdom guidelines recommend assessing competing risks of VTE and bleeding followed by shared decision-making with the patient on prescription of pharmacological thromboprophylaxis VTE thromboprophylaxis However current American College of Chest Physicians ACCP guidelines do not recommend VTE thromboprophylaxis for this group The largest study carried out to date the Prevention of Thrombosis after Lower Leg Plaster Cast POT-CAST randomised controlled trial 1 identified a very low rate of VTE 18 in the non-intervention arm This study concluded that thromboprophylaxis was not justified for patients with lower limb trauma who required lower limb immobilisation However it recommended that further studies are required to see if it is possible to identify a high risk cohort of patients who may benefit from VTE thromboprophylaxis No large prospective study has been published to date to assess if it is possible to identify this high risk group
The Multiple Environmental and Genetic Assessment of risk factors for venous thrombosis MEGA study was a case-control study designed to identify risk factors for a first VTE A sub-analysis of this study reviewed 230 patients who had lower limb trauma with cast immobilisation who developed VTE Based on this data a risk assessment score was derived termed L-TRiP Leiden-Thrombosis Risk Prediction for patients with cast immobilization score in order to identify high risk patients who may benefit from VTE prophylaxis However this risk assessment tool has not been prospectively validated in a study
We have carried out a pilot study to assess the feasibility of a large scale adequately powered multi-centre study aimed at prospective identification of a high VTE-risk group of patients This study was presented at the International Society on Thrombosis and Haemostasis meeting in Berlin in 20175 Utilizing data from this pilot study we now aim to perform a multi-centre study with sufficient power to determine whether it is feasible to identify a high risk group of patients with lower limb trauma requiring immobilisation who will benefit from thromboprophylaxis The POT-CAST study determined that the rate of venous thrombo-embolism VTE in patients with lower limb trauma requiring a cast was 18 This low rate does not justify VTE prophylaxis for all patients who require a cast However there may be a high risk group with a rate of VTE high enough to suggest that consideration of VTE prophylaxis may be appropriate This study will prospectively gather risk factor data on patients at the time of initial presentation post trauma with follow up at 12 weeks to identify those patients who have experienced a symptomatic VTE episode This data will then be used to identify a group with a high VTE risk which future studies can utilise to target this high risk group to assess if VTE prophylaxis is of benefit
The Multiple Environmental and Genetic Assessment of risk factors for venous thrombosis MEGA study was a case-control study designed to identify risk factors for a first VTE A sub-analysis of this study reviewed 230 patients who had lower limb trauma with cast immobilisation who developed VTE Based on this data a risk assessment score was derived termed L-TRiP Leiden-Thrombosis Risk Prediction for patients with cast immobilization score in order to identify high risk patients who may benefit from VTE prophylaxis However this risk assessment tool has not been prospectively validated in a study
We have carried out a pilot study to assess the feasibility of a large scale adequately powered multi-centre study aimed at prospective identification of a high VTE-risk group of patients This study was presented at the International Society on Thrombosis and Haemostasis meeting in Berlin in 20175 Utilizing data from this pilot study we now aim to perform a multi-centre study with sufficient power to determine whether it is feasible to identify a high risk group of patients with lower limb trauma requiring immobilisation who will benefit from thromboprophylaxis The POT-CAST study determined that the rate of venous thrombo-embolism VTE in patients with lower limb trauma requiring a cast was 18 This low rate does not justify VTE prophylaxis for all patients who require a cast However there may be a high risk group with a rate of VTE high enough to suggest that consideration of VTE prophylaxis may be appropriate This study will prospectively gather risk factor data on patients at the time of initial presentation post trauma with follow up at 12 weeks to identify those patients who have experienced a symptomatic VTE episode This data will then be used to identify a group with a high VTE risk which future studies can utilise to target this high risk group to assess if VTE prophylaxis is of benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None