Hip Replacement, TotalPhase 4NCT03623789

Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty

A Phase 4 study testing intravenous application of tranexamic acid, Floseal hemostatic matrix and Normal saline in people with Hip Replacement, Total, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Total hip arthroplasty (THA) is an excellent surgical procedure for patients with end-stage hip diseases. However, THA is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA) was reportedly effective reducing total blood loss (TBL) after standard THA. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Hip Replacement, Total
What is being tested?: intravenous application of tranexamic acid, Floseal hemostatic matrix and Normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteTaiwan
Study dates: 15 Aug 2018to 31 Jul 2020
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 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients with osteoarthritis of the hip secondary to degeneration, inflammatory arthritis, gouty arthritis, acetabular dysplasia or osteonecrosis of the femoral head, and undergoing primary unilateral minimally invasive THA
Age > 18 years and < 90 years
Failure of medical treatment or rehabilitation.
Hemoglobin > 11g/dl,
No use of non-steroid anti-inflammatory agent one week before operation

Who cannot join

Preoperative Hemoglobin ≦11 g/dl
History of infection or intraarticular fracture of the affective hip
Renal function deficiency (GFR <30 ml/min/1.73m2)
Elevated liver enzyme (aspartate transaminase (AST)/ alanine transaminase(ALT) level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
History of deep vein thrombosis, ischemic heart disease or stroke
Contraindications of tranexamic acid, floseal, or rivaroxaban

Show all 11Show fewer

Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
History of heparin-induced thrombocytopenia (HIT)
Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
Patient who have active bleeding disorder, such as intracranial hemorrhage, upper gastrointestinal bleeding, hematuria.
Patients with known allergies to materials of bovine origin.

Trial locations and contacts

1 site in 1 country.

Jun-Wen Wang, MD contact

886-7-7317123

wangjw@adm.cgmh.org.tw

Taiwan1 site, 1 recruiting

Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Jun-Wen Wang, MD, 886-7-7317123, wangjw@adm.cgmh.org.tw
Recruiting

Other trials in Taiwan

About this study

Official title: Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application, a Comparison With Intravenous Tranexamic Acid Only in Total Hip Arthroplasty

Floseal (Baxter, Deerfield, Illinois), a thrombin-based hemostatic agent, have been widely used in surgical procedure. However, there is no study investigating the effect of Floseal in THA procedures.This study anticipated that combination with the two different mechanism of topical hemostatic agent, Floseal, and intravenous TXA can bring a synergistic blood saving effect in THA patients.

Purpose:

Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and topical Floseal in a primary THA procedure.

Material and Methods:

The patients who are enrolled in this study will be assigned into three groups. The first group will be treated by combination of 1 g of TXA pre-operatively and two boluses TXA post-operatively intravenously and Floseal topical application, the second group by 1 g of TXA pre-operatively and two boluses TXA postoperatively intravenously without Floseal use, and the third group was control group which will be treated without TXA and Floseal. This study will observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement between these three groups.

This study anticipate that combined use of intravenous TXA and Floseal in THA procedure is more effective in decreasing blood loss and blood transfusion than intravenous TXA application alone, and this formula do not increase the risk of thromboembolic disease.

Conditions: Hip Replacement, Total
Being tested: intravenous application of tranexamic acid, Floseal hemostatic matrix, Normal saline
Keywords: Total hip arthroplasty, Tranexamic acid, Floseal, postoperative blood loss, Thrombin
Medical subject headings: Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intravenous application of tranexamic acidDrug
Also called transamine
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Floseal hemostatic matrixDrug
Also called Floseal
application of Floseal® on potential bleeding sites after prosthesis implantation
Normal salineDrug
Also called saline
Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.

Study groups in NCT03623789
Study group	Role	What they receive
Group I	Active comparator	Primary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later Receives: Drug: intravenous application of tranexamic acid; Drug: Floseal hemostatic matrix
Group II	Active comparator	Primary total hip replacement with intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later Receives: Drug: intravenous application of tranexamic acid
Group III	Placebo comparator	Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Blood Loss
The total blood loss was calculated according to Nadler et al, which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Measured: Post op day 4
Acute intraoperative Blood Loss
The intra-operative blood loss was recorded according to the volume of contents of the suction bottle and the estimated blood loss through weighing the swabs. The blood loss volume (ml) will be the volume of contents of the suction plus the increasing weight (gm) of swabs (supposing the proportion of blood is 1 gm/mL)
Measured: At the end of operation
The change of Hemoglobin level
Check postoperative Hemoglobin level on postoperative day 1,2,4
Measured: Preoperative day 1 to Post op day 4

Secondary outcomes (3)

Blood transfusion rate
We will record the event of blood transfusion, and calculate the incidence of transfusion
Measured: Within 3 months after operation
Thrombosis risk evaluation
Detect the presence of deep-vein thrombosis of both lower limbs by duplex ultrasound study before discharge
Measured: Within 3 months after operation
Incidence of wound complications
Wound complications including hematoma, skin necrosis and infection
Measured: Within 3 months after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201831 Jul 2020

First posted9 Aug 2018
Study start15 Aug 2018
Primary completion31 Jul 2020 (estimated)
Study completion31 Jul 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Hip Replacement, TotalStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03623789
Sponsor's protocol ID: 201701718A3
Status last verified: Jan 2020
First submitted: 1 Aug 2018
Last updated: 18 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Callaghan JJ, O'Rourke MR, Liu SS. Blood management: issues and options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):51-4. doi: 10.1016/j.arth.2005.03.018.
PubMed 15991130
Kubota R, Nozawa M, Matsuda K, Maezawa K, Kim SG, Maeda K, Ikegami T, Hayashi K, Nagayama M, Kaneko H. Combined preoperative autologous blood donation and intra-operative cell salvage for hip surgery. J Orthop Surg (Hong Kong). 2009 Dec;17(3):288-90. doi: 10.1177/230949900901700308.
PubMed 20065365
Smith LK, Williams DH, Langkamer VG. Post-operative blood salvage with autologous retransfusion in primary total hip replacement. J Bone Joint Surg Br. 2007 Aug;89(8):1092-7. doi: 10.1302/0301-620X.89B8.18736.
PubMed 17785752
Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.
PubMed 9973048
Newman ET, Watters TS, Lewis JS, Jennings JM, Wellman SS, Attarian DE, Grant SA, Green CL, Vail TP, Bolognesi MP. Impact of perioperative allogeneic and autologous blood transfusion on acute wound infection following total knee and total hip arthroplasty. J Bone Joint Surg Am. 2014 Feb 19;96(4):279-84. doi: 10.2106/JBJS.L.01041.
PubMed 24553883
Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2.
PubMed 19188662
Allain JP, Stramer SL, Carneiro-Proietti AB, Martins ML, Lopes da Silva SN, Ribeiro M, Proietti FA, Reesink HW. Transfusion-transmitted infectious diseases. Biologicals. 2009 Apr;37(2):71-7. doi: 10.1016/j.biologicals.2009.01.002. Epub 2009 Feb 20.
PubMed 19231236
Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.
PubMed 16156456
Kazemi SM, Mosaffa F, Eajazi A, Kaffashi M, Daftari Besheli L, Bigdeli MR, Zanganeh RF. The effect of tranexamic acid on reducing blood loss in cementless total hip arthroplasty under epidural anesthesia. Orthopedics. 2010 Jan;33(1):17. doi: 10.3928/01477447-20091124-30.
PubMed 20055345
McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray. Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
PubMed 21999623
Yue C, Kang P, Yang P, Xie J, Pei F. Topical application of tranexamic acid in primary total hip arthroplasty: a randomized double-blind controlled trial. J Arthroplasty. 2014 Dec;29(12):2452-6. doi: 10.1016/j.arth.2014.03.032. Epub 2014 Mar 29.
PubMed 24793893
Chen S, Wu K, Kong G, Feng W, Deng Z, Wang H. The efficacy of topical tranexamic acid in total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Feb 16;17:81. doi: 10.1186/s12891-016-0923-0.
PubMed 26878845
Hsu CH, Lin PC, Kuo FC, Wang JW. A regime of two intravenous injections of tranexamic acid reduces blood loss in minimally invasive total hip arthroplasty: a prospective randomised double-blind study. Bone Joint J. 2015 Jul;97-B(7):905-10. doi: 10.1302/0301-620X.97B7.35029.
PubMed 26130344
Xie J, Ma J, Yao H, Yue C, Pei F. Multiple Boluses of Intravenous Tranexamic Acid to Reduce Hidden Blood Loss After Primary Total Knee Arthroplasty Without Tourniquet: A Randomized Clinical Trial. J Arthroplasty. 2016 Nov;31(11):2458-2464. doi: 10.1016/j.arth.2016.04.034. Epub 2016 May 6.
PubMed 27262419
Seyednejad H, Imani M, Jamieson T, Seifalian AM. Topical haemostatic agents. Br J Surg. 2008 Oct;95(10):1197-225. doi: 10.1002/bjs.6357.
PubMed 18763249

Want to know more?

Jun-Wen Wang, MD

886-7-7317123

wangjw@adm.cgmh.org.tw

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

All Hip Replacement, Total trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application, a Comparison With Intravenous Tranexamic Acid Only in Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT03623789
Acronym / sponsor ID: 201701718A3
Conditions: Hip Replacement, Total
Keywords: Total hip arthroplasty, Tranexamic acid, Floseal, postoperative blood loss, Thrombin
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 15 Aug 2018 (actual)
Primary completion: 31 Jul 2020 (estimated)
Study completion: 31 Jul 2020 (estimated)
First posted: 9 Aug 2018 (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.

Purpose:

Material and Methods:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group I	Active comparator	Drug: intravenous application of tranexamic acid, Drug: Floseal hemostatic matrixPrimary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Group II	Active comparator	Drug: intravenous application of tranexamic acidPrimary total hip replacement with intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Group III	Placebo comparator	Drug: Normal salineControl group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with osteoarthritis of the hip secondary to degeneration, inflammatory arthritis, gouty arthritis, acetabular dysplasia or osteonecrosis of the femoral head, and undergoing primary unilateral minimally invasive THA
Age > 18 years and < 90 years
Failure of medical treatment or rehabilitation.
Hemoglobin > 11g/dl,
No use of non-steroid anti-inflammatory agent one week before operation

Key exclusion criteria (11 listed)

Preoperative Hemoglobin ≦11 g/dl
History of infection or intraarticular fracture of the affective hip
Renal function deficiency (GFR <30 ml/min/1.73m2)
Elevated liver enzyme (aspartate transaminase (AST)/ alanine transaminase(ALT) level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
History of deep vein thrombosis, ischemic heart disease or stroke

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
intravenous application of tranexamic acidAlso: transamineintravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.	Drug	Group I, Group II
Floseal hemostatic matrixAlso: Flosealapplication of Floseal® on potential bleeding sites after prosthesis implantation	Drug	Group I
Normal salineAlso: salineEquivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.	Drug	Group III

Primary outcome

Total Blood Loss
Time frame: Post op day 4
The total blood loss was calculated according to Nadler et al, which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Acute intraoperative Blood Loss
Time frame: At the end of operation
The intra-operative blood loss was recorded according to the volume of contents of the suction bottle and the estimated blood loss through weighing the swabs. The blood loss volume (ml) will be the volume of contents of the suction plus the increasing weight (gm) of swabs (supposing the proportion of blood is 1 gm/mL)
The change of Hemoglobin level
Time frame: Preoperative day 1 to Post op day 4
Check postoperative Hemoglobin level on postoperative day 1,2,4

3 secondary outcomes

Blood transfusion rate
Time frame: Within 3 months after operation
Thrombosis risk evaluation
Time frame: Within 3 months after operation
Incidence of wound complications
Time frame: Within 3 months after operation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Background: PubMed 15991130Callaghan JJ, O'Rourke MR, Liu SS. Blood management: issues and options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):51-4. doi: 10.1016/j.arth.2005.03.018.
Background: PubMed 20065365Kubota R, Nozawa M, Matsuda K, Maezawa K, Kim SG, Maeda K, Ikegami T, Hayashi K, Nagayama M, Kaneko H. Combined preoperative autologous blood donation and intra-operative cell salvage for hip surgery. J Orthop Surg (Hong Kong). 2009 Dec;17(3):288-90. doi: 10.1177/230949900901700308.
Background: PubMed 17785752Smith LK, Williams DH, Langkamer VG. Post-operative blood salvage with autologous retransfusion in primary total hip replacement. J Bone Joint Surg Br. 2007 Aug;89(8):1092-7. doi: 10.1302/0301-620X.89B8.18736.
Background: PubMed 9973048Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.
Background: PubMed 24553883Newman ET, Watters TS, Lewis JS, Jennings JM, Wellman SS, Attarian DE, Grant SA, Green CL, Vail TP, Bolognesi MP. Impact of perioperative allogeneic and autologous blood transfusion on acute wound infection following total knee and total hip arthroplasty. J Bone Joint Surg Am. 2014 Feb 19;96(4):279-84. doi: 10.2106/JBJS.L.01041.
Background: PubMed 19188662Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2.
Background: PubMed 19231236Allain JP, Stramer SL, Carneiro-Proietti AB, Martins ML, Lopes da Silva SN, Ribeiro M, Proietti FA, Reesink HW. Transfusion-transmitted infectious diseases. Biologicals. 2009 Apr;37(2):71-7. doi: 10.1016/j.biologicals.2009.01.002. Epub 2009 Feb 20.
Background: PubMed 16156456Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.
Background: PubMed 20055345Kazemi SM, Mosaffa F, Eajazi A, Kaffashi M, Daftari Besheli L, Bigdeli MR, Zanganeh RF. The effect of tranexamic acid on reducing blood loss in cementless total hip arthroplasty under epidural anesthesia. Orthopedics. 2010 Jan;33(1):17. doi: 10.3928/01477447-20091124-30.
Background: PubMed 21999623McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray. Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
Background: PubMed 24793893Yue C, Kang P, Yang P, Xie J, Pei F. Topical application of tranexamic acid in primary total hip arthroplasty: a randomized double-blind controlled trial. J Arthroplasty. 2014 Dec;29(12):2452-6. doi: 10.1016/j.arth.2014.03.032. Epub 2014 Mar 29.
Background: PubMed 26878845Chen S, Wu K, Kong G, Feng W, Deng Z, Wang H. The efficacy of topical tranexamic acid in total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Feb 16;17:81. doi: 10.1186/s12891-016-0923-0.
Individual participant dataSharing planned: Undecided

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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.

Jun-Wen Wang, MD contact

886-7-7317123

wangjw@adm.cgmh.org.tw

Jun-Wen Wang, MD study chair

Chang Gung Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 Taiwan. 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun-Wen Wang, MD (886-7-7317123, wangjw@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Blood Loss (time frame: Post op day 4). The study lists 3 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 NCT03623789, which also lists 25 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 18 Jan 2020.