Venous Thrombosis Deep (Limbs)Phase 4NCT05081375
Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures
A Phase 4 study testing Enoxaparin Injectable Product and Sodium chloride in people with Venous Thrombosis Deep (Limbs) and Surgical Blood Loss, run by Valleywise Health at 1 site in United States.
Trial summary
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis Deep (Limbs), Surgical Blood Loss
- What is being tested?
- Enoxaparin Injectable Product and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 2 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Traumatic injury of long bones or pelvis requiring surgical intervention
- Admission to the ICU
Who cannot join
- Age < 18 years
- Intracranial hemorrhage
- Direct admit to OR without prior ICU admission
- Pregnancy
- Prisoner
- Chronic Kidney Disease requiring dialysis or a glomerular filtration rate (GFR) or creatinine clearance requiring a decrease in Enoxaparin dosage
- Presence of DVT prior to study drug dose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blinded, Controlled, Randomized Study of the Safety of Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
Read the detailed description
This study will be conducted in an Intensive Care Unit (ICU) and Operating Room (OR) of Valleywise Health Medical Center. The study population will include adult subjects age ≥ 18 years of age, that require surgery for management of their traumatic long bone and/or pelvic fractures.
A total of 60 evaluable subjects will be enrolled in this pilot safety study, with a 1:1 randomization into each group. It is anticipated that approximately 70 patients will need to be consented to reach 60 evaluable subjects.
Subjects recruited for study participation must meet all study enrollment criteria prior to being enrolled in the study. Patients who meet inclusion / exclusion criteria will be invited to participate in the study. As feasible, the patient or his/her representative will be approached for enrollment in the study and asked to provide informed consent for participation.
Written informed consent will be obtained for all subjects by an investigator or delegate prior to enrollment in the study. All subjects meeting inclusion/exclusion criteria will be randomized to either enoxaparin or placebo.
Patients will be monitored for bleeding complications from the time of test article administration to 24 hours post-surgery. Subjects will be monitored for the development of DVT and/or PE through-out their hospitalization.
Subjects will be randomized to either 30 mg enoxaparin Sub Cutaneous (SQ) of 0.9% Sodium Chloride (NaCl) placebo SQ. Randomization will be 1:1, using a masked randomization list. Study personnel and the treatment team will be blinded to the randomization assignment. The Clinical Research Manager and pharmacy staff will be un-blinded and will not participate in study assessments.
The two groups will be treated as follows:
Treatment Group:
Enoxaparin 30mg/0.3ml SQ will be given within 12 hours prior to surgery. If surgery should be delayed longer than 12 hours following the initial dose a second dose will be given to ensure uninterrupted dosing.
If the patient is already on Lovenox 12 hours prior to surgery, no doses will be skipped.
Placebo Group Normal Saline (0.9%) 0.3 ml SQ will be given within 12 hours prior to surgery If surgery should be delayed longer than 12 hours following the initial dose a second dose of normal saline will be given to ensure the appearance of uninterrupted dosing in order to maintain the blind.
If the patient is already being given Enoxaparin 12 hours prior to surgery, the dose 12 hours prior to surgery will be substituted with normal saline.
Both groups
Will receive routine administration of Enoxaparin 12 hours following surgery
Will be monitored at 12 hours and 24 hours post procedure for any evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) formation.
Will be monitored during surgery, at 12 hrs and 24 hrs post-operatively for any bleeding events. A bleeding event is present if one or more of the following are present:
A drop of 3mg/dl or more in hemoglobin, Transfusion of blood product, Intervention/surgery for bleeding (hematoma, hemorrhage)
The following information will be collected and recorded:
Demographics: name, age, race, ethnicity, height, weight, physical exam
- Medical history
- Acute trauma history
- Surgical data: procedure, length of surgery, estimated blood loss
- Lab results
- Imaging results
- Bleeding complications
- DVT and PE events
- Outcome data (length of stay, ICU days, vent days, complications, disposition, etc.)
- Unanticipated problems
- Being tested
- Enoxaparin Injectable Product, Sodium chloride
- Keywords
- prophylaxis of DVT
- Medical subject headings
- Venous Thrombosis, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Injectable ProductDrug
Also called Lovenox
Not holding prophylaxis dose prior to surgical procedure
Sodium chlorideDrug
Also called Placebo
Holding prophylaxis dose of Enoxaparin replacing with placebo
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Active comparator | Enoxaparin dose will not be held for surgical procedure. Receives: Drug: Enoxaparin Injectable Product |
| Placebo dose given and Enoxaparin dose held | Placebo comparator | Enoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure. Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Bleeding Complications Related to DVT chemoprophylaxis
Evaluate the rate of bleeding complications related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
Measured: From the time of study drug administration to 24 hours post-operation
Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis
Evaluate the rate of other complications (besides bleeding) Related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
Measured: From the time of study drug administration to 24 hours post-operation
Secondary outcomes (3)
Incidence of DVT and PE
Recording any incidence of deep vein thrombosis or pulmonary embolism
Measured: From the time of study drug administration to hospital discharge up to 3 months
study duration
Record the time required to complete study enrollment goals
Measured: From Institutional Review Board approval to date of last subject completion up to 2 years
Assess feasibility of a larger trial with respect to study design
Assess a superiority study design using the rates of development of DVT/PE.
Measured: Duration of the study up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start16 Dec 2019
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thrombosis Deep (Limbs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, Controlled, Randomized, Safety Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Wertin, MD, FACS, Principal investigator, Valleywise Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081375
- Sponsor's protocol ID
- 2019-071
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Controlled, Randomized Study of the Safety of Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures
- ClinicalTrials.gov ID
- NCT05081375
- Acronym / sponsor ID
- 2019-071
- Keywords
- prophylaxis of DVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
Detailed description
This study will be conducted in an Intensive Care Unit (ICU) and Operating Room (OR) of Valleywise Health Medical Center. The study population will include adult subjects age ≥ 18 years of age, that require surgery for management of their traumatic long bone and/or pelvic fractures.
A total of 60 evaluable subjects will be enrolled in this pilot safety study, with a 1:1 randomization into each group. It is anticipated that approximately 70 patients will need to be consented to reach 60 evaluable subjects.
Subjects recruited for study participation must meet all study enrollment criteria prior to being enrolled in the study. Patients who meet inclusion / exclusion criteria will be invited to participate in the study. As feasible, the patient or his/her representative will be approached for enrollment in the study and asked to provide informed consent for participation.
Written informed consent will be obtained for all subjects by an investigator or delegate prior to enrollment in the study. All subjects meeting inclusion/exclusion criteria will be randomized to either enoxaparin or placebo.
Patients will be monitored for bleeding complications from the time of test article administration to 24 hours post-surgery. Subjects will be monitored for the development of DVT and/or PE through-out their hospitalization.
Subjects will be randomized to either 30 mg enoxaparin Sub Cutaneous (SQ) of 0.9% Sodium Chloride (NaCl) placebo SQ. Randomization will be 1:1, using a masked randomization list. Study personnel and the treatment team will be blinded to the randomization assignment. The Clinical Research Manager and pharmacy staff will be un-blinded and will not participate in study assessments.
The two groups will be treated as follows:
Treatment Group:
Enoxaparin 30mg/0.3ml SQ will be given within 12 hours prior to surgery. If surgery should be delayed longer than 12 hours following the initial dose a second dose will be given to ensure uninterrupted dosing.
If the patient is already on Lovenox 12 hours prior to surgery, no doses will be skipped.
Placebo Group Normal Saline (0.9%) 0.3 ml SQ will be given within 12 hours prior to surgery If surgery should be delayed longer than 12 hours following the initial dose a second dose of normal saline will be given to ensure the appearance of uninterrupted dosing in order to maintain the blind.
If the patient is already being given Enoxaparin 12 hours prior to surgery, the dose 12 hours prior to surgery will be substituted with normal saline.
Both groups
Will receive routine administration of Enoxaparin 12 hours following surgery
Will be monitored at 12 hours and 24 hours post procedure for any evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) formation.
Will be monitored during surgery, at 12 hrs and 24 hrs post-operatively for any bleeding events. A bleeding event is present if one or more of the following are present:
A drop of 3mg/dl or more in hemoglobin, Transfusion of blood product, Intervention/surgery for bleeding (hematoma, hemorrhage)
The following information will be collected and recorded:
Demographics: name, age, race, ethnicity, height, weight, physical exam
- Medical history
- Acute trauma history
- Surgical data: procedure, length of surgery, estimated blood loss
- Lab results
- Imaging results
- Bleeding complications
- DVT and PE events
- Outcome data (length of stay, ICU days, vent days, complications, disposition, etc.)
- Unanticipated problems
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Blinded, Controlled, Randomized, Safety Study
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Active comparator | Drug: Enoxaparin Injectable ProductEnoxaparin dose will not be held for surgical procedure. |
| Placebo dose given and Enoxaparin dose held | Placebo comparator | Drug: Sodium chlorideEnoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Traumatic injury of long bones or pelvis requiring surgical intervention
- Admission to the ICU
Key exclusion criteria (7 listed)
- Age < 18 years
- Intracranial hemorrhage
- Direct admit to OR without prior ICU admission
- Pregnancy
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin Injectable ProductAlso: LovenoxNot holding prophylaxis dose prior to surgical procedure | Drug | Enoxaparin |
| Sodium chlorideAlso: PlaceboHolding prophylaxis dose of Enoxaparin replacing with placebo | Drug | Placebo dose given and Enoxaparin dose held |
Primary outcome
Evaluate Bleeding Complications Related to DVT chemoprophylaxis
Time frame: From the time of study drug administration to 24 hours post-operation
Evaluate the rate of bleeding complications related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis
Time frame: From the time of study drug administration to 24 hours post-operation
Evaluate the rate of other complications (besides bleeding) Related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
3 secondary outcomes
Incidence of DVT and PE
Time frame: From the time of study drug administration to hospital discharge up to 3 months
study duration
Time frame: From Institutional Review Board approval to date of last subject completion up to 2 years
Assess feasibility of a larger trial with respect to study design
Time frame: Duration of the study up to 2 years
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wertin, MD, FACS principal investigator
Valleywise Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin Injectable Product and Sodium chloride in people with Venous Thrombosis Deep (Limbs) and Surgical Blood Loss, run by Valleywise Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Bleeding Complications Related to DVT chemoprophylaxis (time frame: From the time of study drug administration to 24 hours post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.