Blood Loss, PostoperativeNCT07625709
EFFECT OF TRANEXAMIC ACID ON PERIOPERATIVE BLOOD LOSS IN REAMED INTRAMEDULLARY NAILING OF DIAPHYSEAL FEMORAL AND TIBIAL FRACTURES: A PROSPECTIVE COMPARATIVE STUDY
A study testing Intervention with Tranexamic Acid in people with Blood Loss, Postoperative and Blood Loss, Surgical, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blood Loss, Postoperative, Blood Loss, Surgical, Femoral Fracture
- What is being tested?
- Intervention with Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 16-60 years
- Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia)
- Patients planned for reamed intramedullary nailing
- Patients willing to provide informed consent
Who cannot join
- Patients with polytrauma
- Fractures requiring open reduction
- Gustilo-Anderson Grade III open fractures
- Known history of coagulopathy
- International Normalized Ratio (INR) > 1.2
- Current use of anticoagulant therapy
Show all 10Show fewer
- Current use of antiplatelet therapy
- Presence of major hepatic failure
- Presence of major renal failure
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati, 45200
About this study
Official title: Effect of Tranexamic Acid on Perioperative Blood Loss in Reamed Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures: A Prospective Comparative Study.
Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Intravenous administration of transxamic acid appears to reduce perioperative damage and the need for blood transfusions in spine surgery. The study is done in patients admitted to Dhulikhel Hospital undergoing elective open spine surgery, to study the efficacy of tranexamic acid in reducing blood loss and need of blood transfusion in patients undergoing spine surgery. Patients undergoing spine surgeries are enrolled and allocated by computer generated randomization into 2 groups, (a) placebo group, receiving 0.9% NaCl, (b) tranexamic acid group, receiving 2 doses of tranexamic acid(15mg/kg). Intraoperative and post-operative blood loss are measured. Study parameters include estimated blood loss, hemoglobin, hematocrit and number of blood transfusions required in post-operative setting. Study parameters are compared across two groups using appropriate statistical tools. This study will help us determine the role of tranexamic acid in reducing perioperative blood loss and need for blood transfusion in patients undergoing spine surgery.
HYPOTHESES OF THE STUDY:
Read more
Null hypothesis (H0): There is no significant effect of tranexamic acid in reduction of blood loss compared to study group Alternate hypothesis (H1): There is significant improved effect of tranexamic acid in reduction of blood loss.
Hence, H0 : Mean of Parameters of Control groups >= mean of parameters of Study groups.
H1: Mean of parameters of Control groups < Mean of parameters of Study groups
- Being tested
- Intervention with Tranexamic Acid, Control group (Normal Saline)
- Keywords
- Femur, Fracture, Intramedullary Nailing, Surgical blood loss, Tibia, Tranexamic acid
- Medical subject headings
- Postoperative Hemorrhage, Blood Loss, Surgical, Femoral Fractures, Tibial Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with Tranexamic AcidDrug
In Tranexamic acid (TXA) group, single intravenous dose of Tranexamic Acid (15mg/kg) diluted in 50 ml of normal saline is administered 30 minutes prior to the induction of anesthesia.
Control group (Normal Saline)Drug
This group receives 50ml of normal saline and is labeled as standard care group.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Group | Experimental | Not described Receives: Drug: Intervention with Tranexamic Acid |
| Placebo/ Standard Care group | Placebo comparator | Not described Receives: Drug: Control group (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss Measured in Milliliters (mL)
Intraoperative blood loss during spine surgery will be measured in milliliters (mL) using suction drain collection and surgical sponge estimation. Lower blood loss indicates better efficacy of tranexamic acid in reducing surgical bleeding.
Measured: 2 years
Postoperative Blood Loss Measured in Milliliters (mL)
Postoperative blood loss will be assessed in milliliters (mL) from surgical drain output collected during the first 24 hours following surgery. Lower postoperative blood loss indicates better efficacy of tranexamic acid.
Measured: 2 years
Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)
Reduction in hemoglobin level will be assessed by comparing preoperative and postoperative hemoglobin values measured in grams per deciliter (g/dL). Smaller reduction in hemoglobin indicates lower perioperative blood loss.
Measured: 2 years
Intraoperative Blood Transfusion Requirement
Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation.
Measured: 2 years
Secondary outcomes (1)
Adverse Effects Related to Tranexamic Acid
Adverse events related to tranexamic acid administration, including thromboembolic events, allergic reactions, or other drug-related complications, will be recorded during hospital stay and follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625709
- Sponsor's protocol ID
- 28/23
- Status last verified
- Apr 2026
- First submitted
- 24 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.
PubMed 28938281Boucher M, Tremblay J, Pelet T, Dartus J, Belzile EL, Pelet S. Topical Versus Systemic Tranexamic Acid to Reduce Blood Loss After Total Knee and Total Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2025 Oct 15;107(20):2300-2309. doi: 10.2106/JBJS.24.01511. Epub 2025 Aug 5.
PubMed 40763214Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2021 Jan 16;2021:6961540. doi: 10.1155/2021/6961540. eCollection 2021.
PubMed 33532495
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Perioperative Blood Loss in Reamed Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures: A Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT07625709
- Acronym / sponsor ID
- 28/23
- Keywords
- Femur, Fracture, Intramedullary Nailing, Surgical blood loss, Tibia, Tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 4 Jun 2026 (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.
Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Intravenous administration of transxamic acid appears to reduce perioperative damage and the need for blood transfusions in spine surgery. The study is done in patients admitted to Dhulikhel Hospital undergoing elective open spine surgery, to study the efficacy of tranexamic acid in reducing blood loss and need of blood transfusion in patients undergoing spine surgery. Patients undergoing spine surgeries are enrolled and allocated by computer generated randomization into 2 groups, (a) placebo group, receiving 0.9% NaCl, (b) tranexamic acid group, receiving 2 doses of tranexamic acid(15mg/kg). Intraoperative and post-operative blood loss are measured. Study parameters include estimated blood loss, hemoglobin, hematocrit and number of blood transfusions required in post-operative setting. Study parameters are compared across two groups using appropriate statistical tools. This study will help us determine the role of tranexamic acid in reducing perioperative blood loss and need for blood transfusion in patients undergoing spine surgery.
HYPOTHESES OF THE STUDY:
Null hypothesis (H0): There is no significant effect of tranexamic acid in reduction of blood loss compared to study group Alternate hypothesis (H1): There is significant improved effect of tranexamic acid in reduction of blood loss.
Hence, H0 : Mean of Parameters of Control groups >= mean of parameters of Study groups.
H1: Mean of parameters of Control groups < Mean of parameters of Study groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Group | Experimental | Drug: Intervention with Tranexamic Acid |
| Placebo/ Standard Care group | Placebo comparator | Drug: Control group (Normal Saline) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 16-60 years
- Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia)
- Patients planned for reamed intramedullary nailing
- Patients willing to provide informed consent
Key exclusion criteria (10 listed)
- Patients with polytrauma
- Fractures requiring open reduction
- Gustilo-Anderson Grade III open fractures
- Known history of coagulopathy
- International Normalized Ratio (INR) > 1.2
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 |
|---|---|---|
| Intervention with Tranexamic AcidIn Tranexamic acid (TXA) group, single intravenous dose of Tranexamic Acid (15mg/kg) diluted in 50 ml of normal saline is administered 30 minutes prior to the induction of anesthesia. | Drug | Tranexamic Acid Group |
| Control group (Normal Saline)This group receives 50ml of normal saline and is labeled as standard care group. | Drug | Placebo/ Standard Care group |
Primary outcome
Intraoperative Blood Loss Measured in Milliliters (mL)
Time frame: 2 years
Intraoperative blood loss during spine surgery will be measured in milliliters (mL) using suction drain collection and surgical sponge estimation. Lower blood loss indicates better efficacy of tranexamic acid in reducing surgical bleeding.
Postoperative Blood Loss Measured in Milliliters (mL)
Time frame: 2 years
Postoperative blood loss will be assessed in milliliters (mL) from surgical drain output collected during the first 24 hours following surgery. Lower postoperative blood loss indicates better efficacy of tranexamic acid.
Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)
Time frame: 2 years
Reduction in hemoglobin level will be assessed by comparing preoperative and postoperative hemoglobin values measured in grams per deciliter (g/dL). Smaller reduction in hemoglobin indicates lower perioperative blood loss.
Intraoperative Blood Transfusion Requirement
Time frame: 2 years
Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation.
1 secondary outcome
Adverse Effects Related to Tranexamic Acid
Time frame: 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 4 Jun 2026.
- Results publication: PubMed 28938281Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.
- Results publication: PubMed 40763214Boucher M, Tremblay J, Pelet T, Dartus J, Belzile EL, Pelet S. Topical Versus Systemic Tranexamic Acid to Reduce Blood Loss After Total Knee and Total Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2025 Oct 15;107(20):2300-2309. doi: 10.2106/JBJS.24.01511. Epub 2025 Aug 5.
- Results publication: PubMed 33532495Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2021 Jan 16;2021:6961540. doi: 10.1155/2021/6961540. eCollection 2021.
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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 Intervention with Tranexamic Acid in people with Blood Loss, Postoperative and Blood Loss, Surgical, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
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 10 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 4 Jun 2026. 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 Nepal. 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.
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?
Intraoperative Blood Loss Measured in Milliliters (mL) (time frame: 2 years). The study lists 4 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 NCT07625709, which also lists 3 linked publications.
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 4 Jun 2026.