Femoral FracturesPhase 4TXA-FemNailNCT07261930
Effectiveness of Tranexamic Acid in Reducing Blood Loss During Femoral Nail Surgery
A Phase 4 study testing Tranexamic Acid in people with Femoral Fractures and Hemorrhage, Surgical, run by Masaka Regional Referral Hospital at 1 site in Uganda.
Trial summary
This clinical study aims to evaluate the safety and effectiveness of administering a single intravenous dose of tranexamic acid (TXA) before surgery to reduce blood loss in patients undergoing open intramedullary nailing for femoral shaft fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fractures, Hemorrhage, Surgical, Tranexamic Acid Use
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUganda
- Study dates
- 1 Oct 2018to 1 May 2019
- 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
- Adults aged 18 years and above
- Patients with isolated, closed femoral shaft fractures
- Scheduled for open intramedullary nail fixation at Mulago National Referral Hospital
- Able and willing to provide written informed consent
Who cannot join
- Injury duration of more than one month
- Patients undergoing repeat surgery for a femoral fracture
- Pathological fractures of the femur
- Patients undergoing ORIF for more than one fracture during the perioperative period
- Known allergy to tranexamic acid
- History of bleeding disorders
- Presence of significant medical comorbidities (e.g., diabetes mellitus, history of deep vein thrombosis, or pulmonary embolism)
- Current use of anticoagulant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Preoperative Intravenous Tranexemic Acid on Reduction of Perioperative Blood Loss in Open Intramedullary Nail Fixation of Femoral Shaft Fractures in Mulago
This clinical study aims to evaluate the safety and effectiveness of administering a single intravenous dose of tranexamic acid (TXA) before surgery to reduce blood loss in patients undergoing open intramedullary nailing for femoral shaft fractures. In many resource-limited settings, including Uganda, this surgical approach is common due to lack of fluoroscopic equipment, and it is known to be associated with significant perioperative blood loss.
Tranexamic acid is an antifibrinolytic agent that helps stabilize blood clots and is widely used to reduce bleeding in major surgeries such as joint replacements and spinal procedures. However, its role in trauma-related open femoral surgeries in low-resource settings remains underexplored.
This study investigates whether preoperative intravenous TXA can safely reduce blood loss and transfusion needs during and after surgery in patients with isolated femoral shaft fractures managed at Mulago National Referral Hospital.
Read the detailed description
This is a prospective, open-label, single-arm cohort study designed to assess the safety and effectiveness of preoperative intravenous tranexamic acid (TXA) in adult patients undergoing open intramedullary nailing for femoral shaft fractures in a resource-limited hospital setting.
The study enrolled 43 adult participants with isolated, closed femoral shaft fractures scheduled for surgical fixation at Mulago National Referral Hospital. Each participant received a single dose of intravenous tranexamic acid (15 mg/kg), administered over 10 minutes approximately 10 minutes prior to skin incision. The dose was prepared and delivered by the anesthetist in the operating theatre.
The primary objective of the study is to estimate perioperative blood loss, assessed by comparing preoperative hemoglobin concentration (taken 2 hours before surgery) to postoperative hemoglobin (taken 72 hours after surgery). Secondary objectives include assessing the proportion of patients requiring blood transfusions and documenting any adverse events associated with TXA administration, such as hypotension, nausea, or allergic reactions.
Surgical procedures were performed using either antegrade or retrograde open intramedullary nailing techniques. Standard perioperative care was provided, including preoperative antibiotics and either spinal or general anesthesia. All blood draws were conducted under aseptic conditions. Transfusion decisions followed standard clinical protocols based on clinical signs and hemoglobin thresholds.
This study is intended to inform clinical practice in low-resource settings by providing data on the potential utility of tranexamic acid in orthopedic trauma surgery where blood conservation is especially critical.
- Conditions
- Femoral Fractures, Hemorrhage, Surgical, Tranexamic Acid Use
- Being tested
- Tranexamic Acid
- Keywords
- Femoral Shaft Fractures, Intramedullary Nailing, Perioperative Hemorrhage, Tranexamic Acid, Orthopedic Surgery, Blood Loss, Surgical, Blood Transfusion, Open Reduction and Internal Fixation, Developing Countries
- Medical subject headings
- Femoral Fractures, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Kapron
Intravenous tranexamic acid (Kapron®, Amoun, Egypt) administered as a single dose of 15 mg/kg, diluted in normal saline and given slowly over 10 minutes, approximately 10 minutes prior to skin incision. The drug was supplied in 500 mg/5 mL ampoules and administered by the anesthetist in the operating theater. This intervention was given once before surgery in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures. No additional doses or postoperative administration of TXA were used.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: IV TXA Before Femoral Nailing | Experimental | Participants in this arm received a single preoperative intravenous dose of tranexamic acid (Kapron®, Amoun Pharma, Egypt) at 15 mg/kg, administered slowly over 10 minutes approximately 10 minutes before skin incision. The intervention was intended to reduce perioperative blood loss in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures at Mulago National Referral Hospital, Uganda. All participants received standard perioperative care, including preoperative antibiotics and anesthesia. No control or placebo group was included in this single-arm, open-label study. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative
Hemoglobin concentration (g/dL) was measured 2 hours before surgery and again 72 hours after surgery. The difference between these two values was used to estimate total perioperative blood loss.
Measured: From 2 hours before surgery to 72 hours after surgery
Secondary outcomes (2)
Proportion of Patients Requiring Perioperative Blood Transfusion
The percentage of patients who received a blood transfusion during the perioperative period following administration of preoperative intravenous tranexamic acid (15 mg/kg). Blood transfusion indications were based on standardized clinical criteria and hemoglobin thresholds.
Measured: From 2 hours before surgery to 72 hours after surgery
Incidence and Profile of Adverse Events Following Tranexamic Acid Administration
Capture and categorize any adverse events or side effects observed following the administration of intravenous tranexamic acid.
Measured: From 2 hours before surgery to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Oct 2018
- Primary completion28 Feb 2019
- Study completion1 May 2019
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 Femoral FracturesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label prospective cohort study where all enrolled participants receive the same intervention - a preoperative intravenous dose of tranexamic acid (15 mg/kg) prior to open intramedullary nailing of femoral shaft fractures. There is no control or comparison group within the trial; outcomes are assessed against pre-defined benchmarks or historical controls.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaka Regional Referral Hospital
- Sponsor type
- Other government
- Collaborators
- Mulago Hospital, Uganda, Makerere University
- Responsible party
- Principal investigator, Kabazzi Kaweesa Paul, Masaka Regional Referral Hospital
- Investigators
- Paul Kabazzi, Principal investigator, Masaka Regional Referral Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261930
- Sponsor's protocol ID
- MskRRH-ORTHO-2025-001
- Acronym
- TXA-FemNail
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD) from this study due to limitations in data anonymization resources, ethical considerations, and the absence of prior consent for data sharing from participants. Additionally, the study was conducted in a single-center setting without provisions for long-term data storage or public data access infrastructure. Future data sharing may be considered upon request and subject to ethical review and approval.
Publications
Kabazzi PK, Sekimpi P, Kironde E, Nsubuga Y, Mirembe E. Effectiveness of preoperative intravenous tranexamic acid on reduction of perioperative blood loss in open intramedullary nail fixation of femoral shaft fractures in a tertiary hospital, Uganda: a prospective cohort study. BMC Musculoskelet Disord. 2026 Apr 14;27(1):442. doi: 10.1186/s12891-026-09793-y.
PubMed 41981532
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoperative Intravenous Tranexemic Acid on Reduction of Perioperative Blood Loss in Open Intramedullary Nail Fixation of Femoral Shaft Fractures in Mulago
- ClinicalTrials.gov ID
- NCT07261930
- Acronym / sponsor ID
- TXA-FemNail / MskRRH-ORTHO-2025-001
- Conditions
- Femoral Fractures, Hemorrhage, Surgical, Tranexamic Acid Use
- Keywords
- Femoral Shaft Fractures, Intramedullary Nailing, Perioperative Hemorrhage, Tranexamic Acid, Orthopedic Surgery, Blood Loss, Surgical, Blood Transfusion, Open Reduction and Internal Fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Masaka Regional Referral HospitalOther government
- Collaborators
- Mulago Hospital, Uganda, Makerere University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 3 Dec 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.
This clinical study aims to evaluate the safety and effectiveness of administering a single intravenous dose of tranexamic acid (TXA) before surgery to reduce blood loss in patients undergoing open intramedullary nailing for femoral shaft fractures. In many resource-limited settings, including Uganda, this surgical approach is common due to lack of fluoroscopic equipment, and it is known to be associated with significant perioperative blood loss.
Tranexamic acid is an antifibrinolytic agent that helps stabilize blood clots and is widely used to reduce bleeding in major surgeries such as joint replacements and spinal procedures. However, its role in trauma-related open femoral surgeries in low-resource settings remains underexplored.
This study investigates whether preoperative intravenous TXA can safely reduce blood loss and transfusion needs during and after surgery in patients with isolated femoral shaft fractures managed at Mulago National Referral Hospital.
Detailed description
This is a prospective, open-label, single-arm cohort study designed to assess the safety and effectiveness of preoperative intravenous tranexamic acid (TXA) in adult patients undergoing open intramedullary nailing for femoral shaft fractures in a resource-limited hospital setting.
The study enrolled 43 adult participants with isolated, closed femoral shaft fractures scheduled for surgical fixation at Mulago National Referral Hospital. Each participant received a single dose of intravenous tranexamic acid (15 mg/kg), administered over 10 minutes approximately 10 minutes prior to skin incision. The dose was prepared and delivered by the anesthetist in the operating theatre.
The primary objective of the study is to estimate perioperative blood loss, assessed by comparing preoperative hemoglobin concentration (taken 2 hours before surgery) to postoperative hemoglobin (taken 72 hours after surgery). Secondary objectives include assessing the proportion of patients requiring blood transfusions and documenting any adverse events associated with TXA administration, such as hypotension, nausea, or allergic reactions.
Surgical procedures were performed using either antegrade or retrograde open intramedullary nailing techniques. Standard perioperative care was provided, including preoperative antibiotics and either spinal or general anesthesia. All blood draws were conducted under aseptic conditions. Transfusion decisions followed standard clinical protocols based on clinical signs and hemoglobin thresholds.
This study is intended to inform clinical practice in low-resource settings by providing data on the potential utility of tranexamic acid in orthopedic trauma surgery where blood conservation is especially critical.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label prospective cohort study where all enrolled participants receive the same intervention - a preoperative intravenous dose of tranexamic acid (15 mg/kg) prior to open intramedullary nailing of femoral shaft fractures. There is no control or comparison group within the trial; outcomes are assessed against pre-defined benchmarks or historical controls.
| Arm | Type | Receives |
|---|---|---|
| Single Arm: IV TXA Before Femoral Nailing | Experimental | Drug: Tranexamic AcidParticipants in this arm received a single preoperative intravenous dose of tranexamic acid (Kapron®, Amoun Pharma, Egypt) at 15 mg/kg, administered slowly over 10 minutes approximately 10 minutes before skin incision. The intervention was intended to reduce perioperative blood loss in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures at Mulago National Referral Hospital, Uganda. All participants received standard perioperative care, including preoperative antibiotics and anesthesia. No control or placebo group was included in this single-arm, open-label study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and above
- Patients with isolated, closed femoral shaft fractures
- Scheduled for open intramedullary nail fixation at Mulago National Referral Hospital
- Able and willing to provide written informed consent
Key exclusion criteria (8 listed)
- Injury duration of more than one month
- Patients undergoing repeat surgery for a femoral fracture
- Pathological fractures of the femur
- Patients undergoing ORIF for more than one fracture during the perioperative period
- Known allergy to tranexamic acid
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 |
|---|---|---|
| Tranexamic AcidAlso: KapronIntravenous tranexamic acid (Kapron®, Amoun, Egypt) administered as a single dose of 15 mg/kg, diluted in normal saline and given slowly over 10 minutes, approximately 10 minutes prior to skin incision. The drug was supplied in 500 mg/5 mL ampoules and administered by the anesthetist in the operating theater. This intervention was given once before surgery in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures. No additional doses or postoperative administration of TXA were used. | Drug | Single Arm: IV TXA Before Femoral Nailing |
Primary outcome
Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative
Time frame: From 2 hours before surgery to 72 hours after surgery
Hemoglobin concentration (g/dL) was measured 2 hours before surgery and again 72 hours after surgery. The difference between these two values was used to estimate total perioperative blood loss.
2 secondary outcomes
Proportion of Patients Requiring Perioperative Blood Transfusion
Time frame: From 2 hours before surgery to 72 hours after surgery
Incidence and Profile of Adverse Events Following Tranexamic Acid Administration
Time frame: From 2 hours before surgery to 72 hours after surgery
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 3 Dec 2025.
- Derived from this study: PubMed 41981532Kabazzi PK, Sekimpi P, Kironde E, Nsubuga Y, Mirembe E. Effectiveness of preoperative intravenous tranexamic acid on reduction of perioperative blood loss in open intramedullary nail fixation of femoral shaft fractures in a tertiary hospital, Uganda: a prospective cohort study. BMC Musculoskelet Disord. 2026 Apr 14;27(1):442. doi: 10.1186/s12891-026-09793-y.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD) from this study due to limitations in data anonymization resources, ethical considerations, and the absence of prior consent for data sharing from participants. Additionally, the study was conducted in a single-center setting without provisions for long-term data storage or public data access infrastructure. Future data sharing may be considered upon request and subject to ethical review and approval.
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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.
Paul Kabazzi principal investigator
Masaka Regional Referral Hospital
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 Tranexamic Acid in people with Femoral Fractures and Hemorrhage, Surgical, run by Masaka Regional Referral Hospital at 1 site in Uganda.
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 4 inclusion and 8 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 3 Dec 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 Uganda. 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?
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?
Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative (time frame: From 2 hours before surgery to 72 hours after surgery). 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 NCT07261930, 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 3 Dec 2025.