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Timing of VTE Prophylaxis in TBI

Primary Purpose

TBI (Traumatic Brain Injury), VTE (Venous Thromboembolism)

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin Sodium 150 MG/ML Prefilled Syringe
Heparin
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for TBI (Traumatic Brain Injury)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Traumatic brain injury
  • Intracranial hemorrhage on CT scan

Exclusion Criteria:

  • Under the age of 18
  • Pregnant
  • Die within 24 hours of admission
  • Hospital stay less than 5 days
  • Contraindications to enoxaparin or heparin
  • Coagulopathy at 24 hours post-injury defined as INR>1.6 aPTT>2x normal, or platelet counts<50k
  • Known history of VTE

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early (24 hours)

Late (72 hours)

Arm Description

Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.

Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable.

Outcomes

Primary Outcome Measures

VTE
Rate of venous thromboembolism (DVT or PE)

Secondary Outcome Measures

Bleeding complications
Rate of expanding intracranial hemorrhage

Full Information

First Posted
January 25, 2017
Last Updated
August 14, 2019
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT03081169
Brief Title
Timing of VTE Prophylaxis in TBI
Official Title
Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment not started due to potential conflicting study at same institution. May renew study in the future.
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.
Detailed Description
This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), VTE (Venous Thromboembolism)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early (24 hours)
Arm Type
Active Comparator
Arm Description
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.
Arm Title
Late (72 hours)
Arm Type
Active Comparator
Arm Description
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Sodium 150 MG/ML Prefilled Syringe
Other Intervention Name(s)
Lovenox
Intervention Description
The same drugs and dosages will be used in both groups, with only the timing being different
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
The same drugs and dosages will be used in both groups, with only the timing being different
Primary Outcome Measure Information:
Title
VTE
Description
Rate of venous thromboembolism (DVT or PE)
Time Frame
Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Secondary Outcome Measure Information:
Title
Bleeding complications
Description
Rate of expanding intracranial hemorrhage
Time Frame
Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic brain injury Intracranial hemorrhage on CT scan Exclusion Criteria: Under the age of 18 Pregnant Die within 24 hours of admission Hospital stay less than 5 days Contraindications to enoxaparin or heparin Coagulopathy at 24 hours post-injury defined as INR>1.6 aPTT>2x normal, or platelet counts<50k Known history of VTE
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Timing of VTE Prophylaxis in TBI

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