Deep Venous ThrombosesPhase 4NCT07243080
Comparative Efficacy of Rivaroxaban and Enoxaparin in Post-Laparotomy DVT Prevention
A Phase 4 study testing rivaroxaban (10mg) and Enoxaparin 40 mg SC in people with Deep Venous Thromboses and Laparotomy Patients, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if rivaroxaban works better than enoxaparin to prevent deep vein thrombosis (DVT) after emergency exploratory laparotomy in adults. It will also learn about the safety of rivaroxaban compared to enoxaparin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Venous Thromboses, Laparotomy Patients
- What is being tested?
- rivaroxaban (10mg) and Enoxaparin 40 mg SC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2025to 15 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male or female patients
- Patients who have undergone emergent exploratory laparotomy for any reason whether traumatic or non-traumatic
- Patients with expected immobility for more than 24 hours
Who cannot join
- Patients with diagnosed pre-operative DVT
- BMI more than 40
- Patient who are on mechanical ventilation post operatively
- Patient with postoperative Myocardial infarction, ischemic heart disease or cerebrovascular accident
- Patients who have undergone limb surgery in addition to exploratory laparotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province, 54570
Syed Asghar Naqi, FCPS, +924299211145, registrar@kemu.edu.pk
Zeeshan Sarwar, FCPS, +923228420433, mzeeshansarwar@gmail.com
About this study
Official title: Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy
The goal of this clinical trial is to learn if rivaroxaban works better than enoxaparin to prevent deep vein thrombosis (DVT) after emergency exploratory laparotomy in adults. It will also learn about the safety of rivaroxaban compared to enoxaparin.
The main questions it aims to answer are:
Read more
Does rivaroxaban lower the number of patients who develop DVT after exploratory laparotomy compared to enoxaparin?
What medical problems or side effects do participants have when taking rivaroxaban versus enoxaparin?
Researchers will compare rivaroxaban (an oral anticoagulant) to enoxaparin (a subcutaneous injection) to see which drug works better to prevent blood clots after surgery.
Participants will:
Take rivaroxaban 10 mg orally once daily for 7 days, or enoxaparin 40 mg subcutaneously once daily for 7 days after surgery
Undergo duplex color Doppler ultrasound scans of the legs on day 5 and day 10 after surgery
Be monitored for bleeding, complications, and other side effects
Read the detailed description
Postoperative venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major and preventable cause of morbidity and mortality after surgery. Patients undergoing emergency exploratory laparotomy are at especially high risk due to prolonged operative times, systemic inflammation, and immobility. While low-molecular-weight heparins (LMWH), such as enoxaparin, are the current standard for prophylaxis, direct oral anticoagulants such as rivaroxaban offer potential advantages in terms of ease of administration, compliance, and patient comfort.
This randomized controlled trial was designed to compare the efficacy and safety of once-daily oral rivaroxaban (10 mg) with once-daily subcutaneous enoxaparin (40 mg) in preventing postoperative DVT in adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore.
Eligible patients were adults aged 18-80 years undergoing emergency laparotomy for traumatic or non-traumatic indications and expected to remain immobile for more than 24 hours postoperatively. Patients with pre-existing DVT, morbid obesity (BMI ≥40), active bleeding risk, mechanical ventilation, myocardial infarction, cerebrovascular accident, or current anticoagulation therapy were excluded.
Participants were randomized using a computer-generated sequence with allocation concealment. Rivaroxaban or enoxaparin was given for 7 days postoperatively, in addition to standard perioperative care and mechanical prophylaxis.
The primary outcome was the incidence of DVT as confirmed by duplex color Doppler ultrasound on postoperative days 5 and 10. Any noncompressible or indistinct venous segment was scored as positive for DVT. Wells scores were also recorded to stratify risk.
The secondary outcomes included bleeding complications, duration of hospital stay, time to ambulation, and cost comparison between the two regimens. Safety assessments focused on clinically significant bleeding events and other adverse reactions.
A total of 212 patients were enrolled (106 in each arm). On day 5, rivaroxaban showed a significantly lower rate of DVT compared to enoxaparin (3.8% vs 12.3%). By day 10, the difference remained significant (8.5% vs 20.8%). Wells scores showed no significant differences between groups. No major bleeding events were reported in either arm.
The findings suggest that rivaroxaban is more effective than enoxaparin in reducing postoperative DVT after emergency exploratory laparotomy without increasing bleeding risk. These results add evidence that rivaroxaban may be a safe and convenient alternative to LMWH for high-risk general surgical patients. However, larger multicenter trials with longer follow-up are needed to confirm safety and evaluate long-term outcomes such as pulmonary embolism and late-onset DVT.
- Conditions
- Deep Venous Thromboses, Laparotomy Patients
- Being tested
- rivaroxaban (10mg), Enoxaparin 40 mg SC
- Keywords
- Deep Vein Thrombosis, Exploratory Laparotomy, Rivaroxaban, Enoxaparin, Venous Thromboembolism, Anticoagulation, Prophylaxis, Randomized Controlled Trial, Thromboprophylaxis
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxaban (10mg)Drug
Also called Xarelto
Name: Drug: Rivaroxaban
Type: Drug
Description: Participants receive rivaroxaban 10 mg orally once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines.
Enoxaparin 40 mg SCDrug
Also called clexane
Name: Drug: Enoxaparin
Type: Drug
Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban Group | Active comparator | Arm 1 Title: Rivaroxaban Group Arm Type: Experimental Intervention Name: Drug: Rivaroxaban Descri Receives: Drug: rivaroxaban (10mg) |
| Enoxaparin Group | Active comparator | Arm 2 Title: Enoxaparin Group
Arm Type: Active Comparator
Intervention Name: Drug: Enoxaparin
Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days after emergency exploratory laparotomy, in addition to standard perioperative care and mechanical prophylaxis. Receives: Drug: Enoxaparin 40 mg SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Deep Vein Thrombosis (DVT)
Presence of DVT in the lower limbs will be assessed by duplex color Doppler ultrasonography on postoperative day 5 and day 10. A noncompressible or indistinct venous segment on ultrasound will be considered positive for DVT. The outcome will be reported as the proportion of participants in each treatment arm who develop DVT.
Measured: Postoperative Day 5 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Oct 2025
- Primary completion10 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosesStudies 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
- This randomized, parallel-group, Phase 4 clinical trial enrolled a total of 212 adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore. Participants were allocated in a 1:1 ratio to one of two arms: Arm 1: Rivaroxaban 10 mg orally once daily for 7 days Arm 2: Enoxaparin 40 mg subcutaneously once daily for 7 days Allocation was performed using a computer-generated randomization sequence with concealment via sealed opaque envelopes. The trial used single masking (outcomes assessor blinded); the radiologist performing duplex ultrasonography and the data analyst were blinded to group allocation. The study compared the two interventions in parallel to evaluate the incidence of postoperative deep vein thrombosis (DVT) on days 5 and 10, as detected by duplex color Doppler ultrasound.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Principal investigator, Muhammad Mashhood Ahmad Shad, Mayo Hospital Lahore
- Investigators
- Ahmad Uzair Qureshi, FCPS, Study chair, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243080
- Sponsor's protocol ID
- DRSHAD-GS-2025-001
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected during the trial (including demographics, clinical variables, Wells scores, ultrasound results, and outcomes) will not be made publicly available. Only aggregated results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy
- ClinicalTrials.gov ID
- NCT07243080
- Acronym / sponsor ID
- DRSHAD-GS-2025-001
- Conditions
- Deep Venous Thromboses, Laparotomy Patients
- Keywords
- Deep Vein Thrombosis, Exploratory Laparotomy, Rivaroxaban, Enoxaparin, Venous Thromboembolism, Anticoagulation, Prophylaxis, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 21 Nov 2025 (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.
The goal of this clinical trial is to learn if rivaroxaban works better than enoxaparin to prevent deep vein thrombosis (DVT) after emergency exploratory laparotomy in adults. It will also learn about the safety of rivaroxaban compared to enoxaparin.
The main questions it aims to answer are:
Does rivaroxaban lower the number of patients who develop DVT after exploratory laparotomy compared to enoxaparin?
What medical problems or side effects do participants have when taking rivaroxaban versus enoxaparin?
Researchers will compare rivaroxaban (an oral anticoagulant) to enoxaparin (a subcutaneous injection) to see which drug works better to prevent blood clots after surgery.
Participants will:
Take rivaroxaban 10 mg orally once daily for 7 days, or enoxaparin 40 mg subcutaneously once daily for 7 days after surgery
Undergo duplex color Doppler ultrasound scans of the legs on day 5 and day 10 after surgery
Be monitored for bleeding, complications, and other side effects
Detailed description
Postoperative venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major and preventable cause of morbidity and mortality after surgery. Patients undergoing emergency exploratory laparotomy are at especially high risk due to prolonged operative times, systemic inflammation, and immobility. While low-molecular-weight heparins (LMWH), such as enoxaparin, are the current standard for prophylaxis, direct oral anticoagulants such as rivaroxaban offer potential advantages in terms of ease of administration, compliance, and patient comfort.
This randomized controlled trial was designed to compare the efficacy and safety of once-daily oral rivaroxaban (10 mg) with once-daily subcutaneous enoxaparin (40 mg) in preventing postoperative DVT in adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore.
Eligible patients were adults aged 18-80 years undergoing emergency laparotomy for traumatic or non-traumatic indications and expected to remain immobile for more than 24 hours postoperatively. Patients with pre-existing DVT, morbid obesity (BMI ≥40), active bleeding risk, mechanical ventilation, myocardial infarction, cerebrovascular accident, or current anticoagulation therapy were excluded.
Participants were randomized using a computer-generated sequence with allocation concealment. Rivaroxaban or enoxaparin was given for 7 days postoperatively, in addition to standard perioperative care and mechanical prophylaxis.
The primary outcome was the incidence of DVT as confirmed by duplex color Doppler ultrasound on postoperative days 5 and 10. Any noncompressible or indistinct venous segment was scored as positive for DVT. Wells scores were also recorded to stratify risk.
The secondary outcomes included bleeding complications, duration of hospital stay, time to ambulation, and cost comparison between the two regimens. Safety assessments focused on clinically significant bleeding events and other adverse reactions.
A total of 212 patients were enrolled (106 in each arm). On day 5, rivaroxaban showed a significantly lower rate of DVT compared to enoxaparin (3.8% vs 12.3%). By day 10, the difference remained significant (8.5% vs 20.8%). Wells scores showed no significant differences between groups. No major bleeding events were reported in either arm.
The findings suggest that rivaroxaban is more effective than enoxaparin in reducing postoperative DVT after emergency exploratory laparotomy without increasing bleeding risk. These results add evidence that rivaroxaban may be a safe and convenient alternative to LMWH for high-risk general surgical patients. However, larger multicenter trials with longer follow-up are needed to confirm safety and evaluate long-term outcomes such as pulmonary embolism and late-onset DVT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, parallel-group, Phase 4 clinical trial enrolled a total of 212 adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore. Participants were allocated in a 1:1 ratio to one of two arms: Arm 1: Rivaroxaban 10 mg orally once daily for 7 days Arm 2: Enoxaparin 40 mg subcutaneously once daily for 7 days Allocation was performed using a computer-generated randomization sequence with concealment via sealed opaque envelopes. The trial used single masking (outcomes assessor blinded); the radiologist performing duplex ultrasonography and the data analyst were blinded to group allocation. The study compared the two interventions in parallel to evaluate the incidence of postoperative deep vein thrombosis (DVT) on days 5 and 10, as detected by duplex color Doppler ultrasound.
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban Group | Active comparator | Drug: rivaroxaban (10mg)Arm 1 Title: Rivaroxaban Group Arm Type: Experimental Intervention Name: Drug: Rivaroxaban Descri |
| Enoxaparin Group | Active comparator | Drug: Enoxaparin 40 mg SCArm 2 Title: Enoxaparin Group Arm Type: Active Comparator Intervention Name: Drug: Enoxaparin Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days after emergency exploratory laparotomy, in addition to standard perioperative care and mechanical prophylaxis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male or female patients
- Patients who have undergone emergent exploratory laparotomy for any reason whether traumatic or non-traumatic
- Patients with expected immobility for more than 24 hours
Key exclusion criteria (5 listed)
- Patients with diagnosed pre-operative DVT
- BMI more than 40
- Patient who are on mechanical ventilation post operatively
- Patient with postoperative Myocardial infarction, ischemic heart disease or cerebrovascular accident
- Patients who have undergone limb surgery in addition to exploratory laparotomy
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 |
|---|---|---|
| rivaroxaban (10mg)Also: XareltoName: Drug: Rivaroxaban Type: Drug Description: Participants receive rivaroxaban 10 mg orally once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines. | Drug | Rivaroxaban Group |
| Enoxaparin 40 mg SCAlso: clexaneName: Drug: Enoxaparin Type: Drug Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines. | Drug | Enoxaparin Group |
Primary outcome
Incidence of Deep Vein Thrombosis (DVT)
Time frame: Postoperative Day 5 and Day 10
Presence of DVT in the lower limbs will be assessed by duplex color Doppler ultrasonography on postoperative day 5 and day 10. A noncompressible or indistinct venous segment on ultrasound will be considered positive for DVT. The outcome will be reported as the proportion of participants in each treatment arm who develop DVT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected during the trial (including demographics, clinical variables, Wells scores, ultrasound results, and outcomes) will not be made publicly available. Only aggregated results will be reported in publications and presentations.
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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.
Ahmad Uzair Qureshi, FCPS study chair
Mayo Hospital Lahore
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 rivaroxaban (10mg) and Enoxaparin 40 mg SC in people with Deep Venous Thromboses and Laparotomy Patients, run by Mayo Hospital Lahore at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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 Pakistan. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Mashhood Shad, FCPS (+923040420285, mashhood_shad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Deep Vein Thrombosis (DVT) (time frame: Postoperative Day 5 and Day 10). 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 21 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.