Knee OsteoarthritisNCT07494708
Hemoglobin Drop and Need for Blood Transfusion in Primary Knee Arthroplasty With or Without Drain Insertion
A study testing Closed Suction Drain Insertion and No Drain Placement in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
Total knee arthroplasty is a common operation performed to relieve pain and improve movement in patients with severe knee joint disease, such as osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or osteonecrosis. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Closed Suction Drain Insertion and No Drain Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 31 Jan 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 80 years.
- Both male and female patients.
- Diagnosed with:
- Primary knee osteoarthritis.
- Rheumatoid arthritis.
- Arthritis following trauma.
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- Osteonecrosis, or avascular necrosis.
- Unilateral primary total knee arthroplasty (TKA) is necessary due to severe knee pain, stiffness, and non-responsiveness to conservative treatment.
- Patients with a Knee Society Score (KSS) of ≤60 are considered to have functional limitations, which are characterized as a severe impairment in activities of daily living (ADLs) related to knee disease.
- Preoperative hemoglobin ≥10 g/dL to ensure comparable baseline hemoglobin levels across groups.
- BMI between 18.5 and 35 kg/m² to exclude extremes of underweight or morbid obesity.
Who cannot join
- Patients undergoing revision TKA due to implant failure, infection, or periprosthetic fractures.
- Individuals with aberrant coagulation parameters (INR >1.5, extended PT/aPTT) or inherited or acquired bleeding diseases (such as hemophilia or von Willebrand disease).
- Patients receiving antiplatelet therapy (ticagrelor, clopidogrel) or long-term anticoagulants (warfarin, DOACs) within seven days of surgery.
- Individuals with sickle cell disease, thalassemia, or chronic anemia (Hb <10 g/dL).
- Individuals with severe COPD, pulmonary hypertension, NYHA Class III or IV heart failure, or a history of DVT/PE within the last six months.
- Severe chronic kidney disease (CKD) stage 4/5 (eGFR <30 mL/min/1.73m²) or severe hepatic dysfunction (Child-Pugh Class C, AST/ALT >3×normal, bilirubin >2 mg/dL).
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- Patients with active systemic infections (sepsis, tuberculosis, HIV/AIDS, hepatitis B/C, osteomyelitis).
- Patients with a history of thromboembolic events (DVT/PE/stroke within 12 months) or contraindications to tranexamic acid (TXA).
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shifa International Hospital, Islamabad
Islamabad, Fedral, 44000
About this study
Total knee arthroplasty is a common operation performed to relieve pain and improve movement in patients with severe knee joint disease, such as osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or osteonecrosis. However, blood loss after surgery remains an important concern because it may lead to a fall in hemoglobin level and increase the need for blood transfusion. Blood transfusion may be necessary in some patients, but it also carries additional risks and cost. One practice that may influence postoperative blood loss is the use of a surgical drain. A drain is commonly placed at the end of surgery to remove blood and fluid from the operated area, but its benefit in total knee arthroplasty remains uncertain. Some studies suggest that drains may reduce blood collection inside the joint, whereas others suggest that they may increase overall blood loss by preventing the natural pressure effect that helps stop bleeding.
This randomized clinical trial is being conducted to compare hemoglobin drop and blood transfusion requirement in patients undergoing primary unilateral total knee arthroplasty with or without drain insertion. A total of 102 patients will be enrolled and randomly allocated into two equal groups. In Group A, a closed suction drain will be inserted at the end of surgery. In Group B, no drain will be used. All operations will be performed using a standardized surgical technique, and all patients will receive similar perioperative care, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation.
Hemoglobin levels will be measured before surgery and again at 24 and 48 hours after surgery. The main outcomes will be the amount of hemoglobin drop after surgery and whether blood transfusion is required. Blood transfusion will be given according to the predefined hospital protocol when hemoglobin falls below 8 g/dL. The study hypothesis is that there is a significant difference in postoperative hemoglobin drop and blood transfusion requirement between patients undergoing primary knee arthroplasty with drain insertion and those undergoing surgery without drain insertion.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Closed Suction Drain Insertion, No Drain Placement
- Keywords
- Total Knee Arthroplasty, Primary Knee Arthroplasty, Surgical Drainage, Closed Suction Drainage, Postoperative Blood Loss
- Medical subject headings
- Osteoarthritis, Knee, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Suction Drain InsertionProcedure or surgery
A closed suction drain will be placed at the surgical site at the end of primary total knee arthroplasty to allow postoperative drainage of blood and fluid.
No Drain PlacementOther
Primary total knee arthroplasty will be performed without insertion of a postoperative surgical drain. Standard perioperative management, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation, will be provided similarly to the drain group.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Drain Insertion Group) | Experimental | Patients undergoing primary unilateral total knee arthroplasty with placement of a closed suction drain at the end of surgery. Receives: Procedure: Closed Suction Drain Insertion |
| Group B (Non-Drain Group) | Other | Patients undergoing primary unilateral total knee arthroplasty without placement of a drain. Receives: Other: No Drain Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hemoglobin drop at 24 hours
Hemoglobin drop will be calculated as the difference between preoperative hemoglobin measured within 24 hours before surgery and postoperative hemoglobin measured 24 hours after primary total knee arthroplasty. Hemoglobin will be measured in g/dL using a standardized laboratory assay.
Measured: 24 hours after surgery
Postoperative hemoglobin drop at 48 hours
Hemoglobin drop will be calculated as the difference between preoperative hemoglobin measured within 24 hours before surgery and postoperative hemoglobin measured 48 hours after primary total knee arthroplasty. Hemoglobin will be measured in g/dL using a standardized laboratory assay.
Measured: 48 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 posted27 Mar 2026
- Study start1 Aug 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnain Ali, Shifa International Hospital
- Investigators
- Hasnain Ali, Principal investigator, Shifa International Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494708
- Sponsor's protocol ID
- SIH1
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin Drop and Need for Blood Transfusion in Primary Knee Arthroplasty With or Without Drain Insertion
- ClinicalTrials.gov ID
- NCT07494708
- Acronym / sponsor ID
- SIH1
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Primary Knee Arthroplasty, Surgical Drainage, Closed Suction Drainage, Postoperative Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 27 Mar 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.
Total knee arthroplasty is a common operation performed to relieve pain and improve movement in patients with severe knee joint disease, such as osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or osteonecrosis. However, blood loss after surgery remains an important concern because it may lead to a fall in hemoglobin level and increase the need for blood transfusion. Blood transfusion may be necessary in some patients, but it also carries additional risks and cost. One practice that may influence postoperative blood loss is the use of a surgical drain. A drain is commonly placed at the end of surgery to remove blood and fluid from the operated area, but its benefit in total knee arthroplasty remains uncertain. Some studies suggest that drains may reduce blood collection inside the joint, whereas others suggest that they may increase overall blood loss by preventing the natural pressure effect that helps stop bleeding.
This randomized clinical trial is being conducted to compare hemoglobin drop and blood transfusion requirement in patients undergoing primary unilateral total knee arthroplasty with or without drain insertion. A total of 102 patients will be enrolled and randomly allocated into two equal groups. In Group A, a closed suction drain will be inserted at the end of surgery. In Group B, no drain will be used. All operations will be performed using a standardized surgical technique, and all patients will receive similar perioperative care, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation.
Hemoglobin levels will be measured before surgery and again at 24 and 48 hours after surgery. The main outcomes will be the amount of hemoglobin drop after surgery and whether blood transfusion is required. Blood transfusion will be given according to the predefined hospital protocol when hemoglobin falls below 8 g/dL. The study hypothesis is that there is a significant difference in postoperative hemoglobin drop and blood transfusion requirement between patients undergoing primary knee arthroplasty with drain insertion and those undergoing surgery without drain insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Drain Insertion Group) | Experimental | Procedure: Closed Suction Drain InsertionPatients undergoing primary unilateral total knee arthroplasty with placement of a closed suction drain at the end of surgery. |
| Group B (Non-Drain Group) | Other | Other: No Drain PlacementPatients undergoing primary unilateral total knee arthroplasty without placement of a drain. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 50 and 80 years.
- Both male and female patients.
- Diagnosed with:
- Primary knee osteoarthritis.
- Rheumatoid arthritis.
Key exclusion criteria (9 listed)
- Patients undergoing revision TKA due to implant failure, infection, or periprosthetic fractures.
- Individuals with aberrant coagulation parameters (INR >1.5, extended PT/aPTT) or inherited or acquired bleeding diseases (such as hemophilia or von Willebrand disease).
- Patients receiving antiplatelet therapy (ticagrelor, clopidogrel) or long-term anticoagulants (warfarin, DOACs) within seven days of surgery.
- Individuals with sickle cell disease, thalassemia, or chronic anemia (Hb <10 g/dL).
- Individuals with severe COPD, pulmonary hypertension, NYHA Class III or IV heart failure, or a history of DVT/PE within the last six months.
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 |
|---|---|---|
| Closed Suction Drain InsertionA closed suction drain will be placed at the surgical site at the end of primary total knee arthroplasty to allow postoperative drainage of blood and fluid. | Procedure or surgery | Group A (Drain Insertion Group) |
| No Drain PlacementPrimary total knee arthroplasty will be performed without insertion of a postoperative surgical drain. Standard perioperative management, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation, will be provided similarly to the drain group. | Other | Group B (Non-Drain Group) |
Primary outcome
Postoperative hemoglobin drop at 24 hours
Time frame: 24 hours after surgery
Hemoglobin drop will be calculated as the difference between preoperative hemoglobin measured within 24 hours before surgery and postoperative hemoglobin measured 24 hours after primary total knee arthroplasty. Hemoglobin will be measured in g/dL using a standardized laboratory assay.
Postoperative hemoglobin drop at 48 hours
Time frame: 48 hours after surgery
Hemoglobin drop will be calculated as the difference between preoperative hemoglobin measured within 24 hours before surgery and postoperative hemoglobin measured 48 hours after primary total knee arthroplasty. Hemoglobin will be measured in g/dL using a standardized laboratory assay.
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 30 Mar 2026.
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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.
Hasnain Ali principal investigator
Shifa International Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Suction Drain Insertion and No Drain Placement in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Shifa International Hospital 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 11 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 30 Mar 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 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.
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?
Postoperative hemoglobin drop at 24 hours (time frame: 24 hours after surgery). 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 30 Mar 2026.