Revision Total Hip Arthroplasty (RTHA)Phase 4NCT02747615
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
A Phase 4 study testing transfused pre-operatively donated autologous blood., intravenous tranexamic acid (TXA) infusion and transfused only allogeneic blood. in people with Revision Total Hip Arthroplasty (RTHA), run by Ain Shams University.
Trial summary
Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Revision Total Hip Arthroplasty (RTHA)
- What is being tested?
- transfused pre-operatively donated autologous blood., intravenous tranexamic acid (TXA) infusion and transfused only allogeneic blood.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.
Who cannot join
- This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.
About this study
Official title: Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty: a Randomized Controlled Trial
Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.
Read the detailed description
A total of 60 patients were included in this randomized study that were divided into a study group of 30 patients, who had been transfused autologous blood and a control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 g of intravenous TXA.
This study was conducted through laboratory analysis of hemoglobin and hematocrit values during blood donation and for both groups in the preoperative and the postoperative period and the assessment of the amount of transfused blood units in both groups.
- Conditions
- Revision Total Hip Arthroplasty (RTHA)
- Being tested
- transfused pre-operatively donated autologous blood., intravenous tranexamic acid (TXA) infusion, transfused only allogeneic blood.
- Keywords
- Autologous blood donation, allogeneic blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfused pre-operatively donated autologous blood.Other
Also called Pre-operative autologous donation
Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion
intravenous tranexamic acid (TXA) infusionDrug
Also called Kapron®
Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.
transfused only allogeneic blood.Other
| Study group | Role | What they receive |
|---|---|---|
| Control group (n=30) | Other | The control group, which consisted of 30 patients who were transfused only allogeneic blood. Receives: Other: transfused only allogeneic blood. |
| Preoperative blood donation (n=30) | Active comparator | the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it. Receives: Other: transfused pre-operatively donated autologous blood.; Drug: intravenous tranexamic acid (TXA) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Transfused Allogeneic Blood Units (in Digits).
Measured: 48-72 hours after surgery.
Secondary outcomes (1)
Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).
Measured: 48-72 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 posted22 Apr 2016 (estimated)
- Study startAug 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Revision Total Hip Arthroplasty (RTHA)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747615
- Sponsor's protocol ID
- 586
- Status last verified
- Sep 2020
- First submitted
- 3 Apr 2016
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02747615
- Acronym / sponsor ID
- 586
- Conditions
- Revision Total Hip Arthroplasty (RTHA)
- Keywords
- Autologous blood donation, allogeneic blood transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.
Detailed description
A total of 60 patients were included in this randomized study that were divided into a study group of 30 patients, who had been transfused autologous blood and a control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 g of intravenous TXA.
This study was conducted through laboratory analysis of hemoglobin and hematocrit values during blood donation and for both groups in the preoperative and the postoperative period and the assessment of the amount of transfused blood units in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (n=30) | Other | Other: transfused only allogeneic blood.The control group, which consisted of 30 patients who were transfused only allogeneic blood. |
| Preoperative blood donation (n=30) | Active comparator | Other: transfused pre-operatively donated autologous blood., Drug: intravenous tranexamic acid (TXA) infusionthe study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.
Key exclusion criteria (1 listed)
- This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.
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 |
|---|---|---|
| transfused pre-operatively donated autologous blood.Also: Pre-operative autologous donationPre-operative autologous donation for minimising perioperative allogeneic blood transfusion | Other | Preoperative blood donation (n=30) |
| intravenous tranexamic acid (TXA) infusionAlso: Kapron®Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery. | Drug | Preoperative blood donation (n=30) |
| transfused only allogeneic blood. | Other | Control group (n=30) |
Primary outcome
Number of Transfused Allogeneic Blood Units (in Digits).
Time frame: 48-72 hours after surgery.
1 secondary outcome
Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).
Time frame: 48-72 hours after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Revision Total Hip Arthroplasty (RTHA)
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transfused pre-operatively donated autologous blood., intravenous tranexamic acid (TXA) infusion and transfused only allogeneic blood. in people with Revision Total Hip Arthroplasty (RTHA), run by Ain Shams University.
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 1 inclusion and 1 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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Transfused Allogeneic Blood Units (in Digits). (time frame: 48-72 hours after surgery.). 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 7 Sep 2020.