BurnsNCT05237726
Efficacy and Safety for Different Regimen of VTE Pharmacoprophylaxis Among Severely Burn Patients
A study testing Enoxaparin 40 mg q24 hours, Enoxaparin 30 mg q12 hours and Unfractionated heparin 5000 U q8 hours in people with Burns, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Enoxaparin 40 mg q24 hours, Enoxaparin 30 mg q12 hours and Unfractionated heparin 5000 U q8 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Apr 2020to 28 Feb 2022
- Phase
- Interventional
- 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
- Burn ICU admitted adult patients, age ≥ 18 years old.
- Body Mass Index of 18.5 to < 40 kg/m2.
- TBSA of 20% or more.
Who cannot join
- VTE history.
- Death within 24 hours of injury.
- Burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours.
- Coagulopathy (INR > 1.7, PTT> 2 times upper normal limit, platelet < 50k mm3)
- Patient with positive baseline US for VTE.
- Heparin induced thrombocytopenia (HIT).
Show all 9Show fewer
- Active bleeding.
- Patients with CrCl of 30 ml/min or less.
- Patients using anticoagulation treatment dose for other indications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy and Safety for Different Regimen of Venous Thromboembolism Pharmacoprophylaxis Among Severely Burn Patients
This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE events.
Read the detailed description
This is a pilot , randomized control trial-Open label, prospective trial in tertiary academic hospitals for patient admitted to burn ICU for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. Each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units S.C. TID, enoxaparin 40 mg S.C. OD, or Enoxaparin 30 mg S.C. BID. VTE prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, VTE prophylaxis should be started immediately unless contraindicated. All patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of DVT and as clinically indicated for clinical suspicion for VTE thereafter until discharge, an urgent spiral CTA chest will be requested on clinical suspicion for PE. Anti Xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. Will follow-up patient until discharge from ICU, developed VTE requiring treatment (switch to treatment dose), developed HIT or death.
- Conditions
- Burns
- Being tested
- Enoxaparin 40 mg q24 hours, Enoxaparin 30 mg q12 hours, Unfractionated heparin 5000 U q8 hours
- Keywords
- Severely burn, BSA≥20%, Enoxaparin, Unfractionated Heparin, VTE, Bleeding
- Medical subject headings
- Burns, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 40 mg q24 hoursDrug
Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.
Enoxaparin 30 mg q12 hoursDrug
Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.
Unfractionated heparin 5000 U q8 hoursDrug
Severely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated Heparin (UFH) 5000 U q8 hours | Active comparator | Severely burn injuries (BSA≥20%) will receive Unfractionated Heparin (UFH) 5000 U q8 hours as pharmacological VTE prophylaxis Receives: Drug: Unfractionated heparin 5000 U q8 hours |
| Enoxaparin 40 mg q24 hours | Active comparator | Severely burn injuries (BSA≥20%) will receive Enoxaparin 40 mg q24 hours as pharmacological VTE prophylaxis Receives: Drug: Enoxaparin 40 mg q24 hours |
| Enoxaparin 30 mg q12 hours | Active comparator | Severely burn injuries (BSA≥20%) will receive Enoxaparin 30 mg q12 hours as pharmacological VTE prophylaxis Receives: Drug: Enoxaparin 30 mg q12 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding events (major and minor)
Daily assessment of major and minor Bleeding. Bleeding will classified into major and minor bleeding. Major bleeding defined as clinically overt bleeding associated with a fall ≥Hb 20g/L, transfusion of ≥2U PRBC or whole blood, retroperitoneal or intracranial bleeding or requiring urgent medical intervention. Minor bleeding defined as those not fulfilling the criteria of major or clinically significant bleeding.
Measured: Through study completion, an average of 2 years
Adverse effects in surgical outcomes (i.e. Graft loss, donor site morbidity, requirement of hemostatic intervention).
Daily assessment of donor site and graft site bleeding/failure.
Graft site bleeding defined as bleeding at skin graft recipient site that requires premature wound exploration ( before 3 days postoperatively), bed side or operating room intervention to stop bleeding ( stitching, hemostatic agent or cauterization) with or without blood transfusion.
Donor site bleeding/hematoma is any bleeding leading to a drop in hemoglobin > 2 grams, hemodynamic instability or bleeding requiring urgent transfusion.
Graft failure due to hematoma that require re-grafting or more than 50% of the graft site.
Enoxaparin should be held 12 hours and unfractionated heparin 3-4 hours before percutaneous tracheostomy OR epidural catheter if indicated.
Measured: Through study completion, an average of 2 years
Recruitment and consent rates
To assess the recruitment and consent rate to evaluate trial feasibility
Measured: Through study completion, an average of 2 years
Secondary outcomes (5)
Target anti Xa factor for enoxaparin or unfractionated heparin in severely burn patients.
Anti-Xa: Blood samples for Anti-Xa were obtained day 3 after patient is admitted to ICU (Plasma sample will be collected in blue tube "no citrate" ~ 5 mL/Test), then Anti-Xa obtained weekly thereafter until discharge. Anti-Xa obtained immediately 4 hours after administration of Enoxaparin and 3 hours after administration of unfractionated Heparin
Measured: Through study completion, an average of 2 years
Incidence of Heparin induced thrombocytopenia (HIT).
Measured: Through study completion, an average of 2 years
Number of days that patients stay in hospital
The length of an inpatient episode of care, calculated from the day of admission in hospital to day of discharge/death
Measured: Through study completion, an average of 2 years
Number of patients died within intensive care unit stay
The number of deaths of patients admitted to the intensive care unit (ICU), divided by the number of patient discharges from the ICU (including deaths and transfers).
Measured: Through study completion, an average of 2 years
Incidence of VTE events (Symptomatic)
All patients participating in the study should undergo bilateral lower extremity duplex scan to rule out DVT at baseline before starting VTE prophylaxis and as clinically indicated for clinical suspicion for VTE thereafter until discharge from ICU, developing VTE incident or death.
Urgent spiral CTA chest will be requested on clinical suspicion for PE.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start5 Apr 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups randomized to receive DVT prophylaxis either enoxaparin 30 mg every 12 hours, enoxaparin 40 mg once daily and unfractionated heparin 5000 units every 8 hours
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KHALID ALSULAIMAN, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237726
- Sponsor's protocol ID
- RC18-400-R
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Sulaiman KA, Al-Ramahi G, Aljuhani O, Al-Joudi K, Alhujayri AK, Al-Shomer F, Silas J, Al Dabbagh T, Al Harbi S, AlDekhayel S, Eldali A, Alqahtani R, Vishwakarma R, Al-Dorzi HM. Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial. Eur J Trauma Emerg Surg. 2024 Apr;50(2):567-579. doi: 10.1007/s00068-024-02443-9. Epub 2024 Jan 19.
PubMed 38240791
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety for Different Regimen of Venous Thromboembolism Pharmacoprophylaxis Among Severely Burn Patients
- ClinicalTrials.gov ID
- NCT05237726
- Acronym / sponsor ID
- RC18-400-R
- Conditions
- Burns
- Keywords
- Severely burn, BSA≥20%, Enoxaparin, Unfractionated Heparin, VTE, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Feb 2022 (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.
This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE events.
Detailed description
This is a pilot , randomized control trial-Open label, prospective trial in tertiary academic hospitals for patient admitted to burn ICU for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. Each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units S.C. TID, enoxaparin 40 mg S.C. OD, or Enoxaparin 30 mg S.C. BID. VTE prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, VTE prophylaxis should be started immediately unless contraindicated. All patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of DVT and as clinically indicated for clinical suspicion for VTE thereafter until discharge, an urgent spiral CTA chest will be requested on clinical suspicion for PE. Anti Xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. Will follow-up patient until discharge from ICU, developed VTE requiring treatment (switch to treatment dose), developed HIT or death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups randomized to receive DVT prophylaxis either enoxaparin 30 mg every 12 hours, enoxaparin 40 mg once daily and unfractionated heparin 5000 units every 8 hours
| Arm | Type | Receives |
|---|---|---|
| Unfractionated Heparin (UFH) 5000 U q8 hours | Active comparator | Drug: Unfractionated heparin 5000 U q8 hoursSeverely burn injuries (BSA≥20%) will receive Unfractionated Heparin (UFH) 5000 U q8 hours as pharmacological VTE prophylaxis |
| Enoxaparin 40 mg q24 hours | Active comparator | Drug: Enoxaparin 40 mg q24 hoursSeverely burn injuries (BSA≥20%) will receive Enoxaparin 40 mg q24 hours as pharmacological VTE prophylaxis |
| Enoxaparin 30 mg q12 hours | Active comparator | Drug: Enoxaparin 30 mg q12 hoursSeverely burn injuries (BSA≥20%) will receive Enoxaparin 30 mg q12 hours as pharmacological VTE prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn ICU admitted adult patients, age ≥ 18 years old.
- Body Mass Index of 18.5 to < 40 kg/m2.
- TBSA of 20% or more.
Key exclusion criteria (9 listed)
- VTE history.
- Death within 24 hours of injury.
- Burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours.
- Coagulopathy (INR > 1.7, PTT> 2 times upper normal limit, platelet < 50k mm3)
- Patient with positive baseline US for VTE.
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 40 mg q24 hoursSeverely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours. | Drug | Enoxaparin 40 mg q24 hours |
| Enoxaparin 30 mg q12 hoursSeverely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours. | Drug | Enoxaparin 30 mg q12 hours |
| Unfractionated heparin 5000 U q8 hoursSeverely burn injuries (BSA≥20%) will be assigned to 3 modality regimens of pharmacological VTE prophylaxis: Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours. | Drug | Unfractionated Heparin (UFH) 5000 U q8 hours |
Primary outcome
Incidence of bleeding events (major and minor)
Time frame: Through study completion, an average of 2 years
Daily assessment of major and minor Bleeding. Bleeding will classified into major and minor bleeding. Major bleeding defined as clinically overt bleeding associated with a fall ≥Hb 20g/L, transfusion of ≥2U PRBC or whole blood, retroperitoneal or intracranial bleeding or requiring urgent medical intervention. Minor bleeding defined as those not fulfilling the criteria of major or clinically significant bleeding.
Adverse effects in surgical outcomes (i.e. Graft loss, donor site morbidity, requirement of hemostatic intervention).
Time frame: Through study completion, an average of 2 years
Daily assessment of donor site and graft site bleeding/failure. Graft site bleeding defined as bleeding at skin graft recipient site that requires premature wound exploration ( before 3 days postoperatively), bed side or operating room intervention to stop bleeding ( stitching, hemostatic agent or cauterization) with or without blood transfusion. Donor site bleeding/hematoma is any bleeding leading to a drop in hemoglobin > 2 grams, hemodynamic instability or bleeding requiring urgent transfusion. Graft failure due to hematoma that require re-grafting or more than 50% of the graft site. Enoxaparin should be held 12 hours and unfractionated heparin 3-4 hours before percutaneous tracheostomy OR epidural catheter if indicated.
Recruitment and consent rates
Time frame: Through study completion, an average of 2 years
To assess the recruitment and consent rate to evaluate trial feasibility
5 secondary outcomes
Target anti Xa factor for enoxaparin or unfractionated heparin in severely burn patients.
Time frame: Through study completion, an average of 2 years
Incidence of Heparin induced thrombocytopenia (HIT).
Time frame: Through study completion, an average of 2 years
Number of days that patients stay in hospital
Time frame: Through study completion, an average of 2 years
Number of patients died within intensive care unit stay
Time frame: Through study completion, an average of 2 years
Incidence of VTE events (Symptomatic)
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 38240791Al Sulaiman KA, Al-Ramahi G, Aljuhani O, Al-Joudi K, Alhujayri AK, Al-Shomer F, Silas J, Al Dabbagh T, Al Harbi S, AlDekhayel S, Eldali A, Alqahtani R, Vishwakarma R, Al-Dorzi HM. Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial. Eur J Trauma Emerg Surg. 2024 Apr;50(2):567-579. doi: 10.1007/s00068-024-02443-9. Epub 2024 Jan 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin 40 mg q24 hours, Enoxaparin 30 mg q12 hours and Unfractionated heparin 5000 U q8 hours in people with Burns, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 9 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: finished, as of the sponsor's last update on 20 Dec 2022. 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 Saudi Arabia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of bleeding events (major and minor) (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237726, which also lists 1 linked publication.
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 20 Dec 2022.