Tissue DonorsNCT03386435
The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy
A study testing remote ischemic preconditioning in people with Tissue Donors and Liver Transplantation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tissue Donors, Liver Transplantation, Ischemia Reperfusion Injury
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2016to 30 Oct 2017
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Donors who plan to have living right hepatectomy for liver transplantation.
- age : between 18 to 60 years.
Who cannot join
- donors who plan to donate left lobe
- donors who plan to have laparoscopic right hepatectomy
- donors who cannot proceed remote ischemic preconditioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remote Ischemic Preconditioning on the Postoperative Liver Function in Living Donor Hepatectomy: a Randomized Clinical Trial
Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.
Read the detailed description
Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).
IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.
Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.
Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.
- Being tested
- remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, liver donors
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningProcedure or surgery
Also called RIPC
Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Experimental | intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. Receives: Procedure: remote ischemic preconditioning |
| Control | No intervention | In the control group, the same maneuver was applied but without cuff inflation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.
Measured: within 7 days after operation
The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy
Measured: within 7 days after operation
Secondary outcomes (2)
Number of Participants With Delayed Recovery of Liver Function
The incidence of delayed recovery of hepatic function (DRHF) were used as surrogate parameters indicating the possible benefits of RIPC. DRHF was defined based on a proposal by the International Study Group of Liver Surgery, as follows: an impaired ability of the liver to maintain its synthetic, excretory, and detoxifying functions, which are characterized by an increased PT INR and concomitant hyperbilirubinemia (considering the normal limits of the local laboratory) on or after postoperative day 5. The normal upper limits of PT and bilirubin in our institutional laboratory were 1.30 INR and 1.2 mg/dL, respectively. If either the PT INR or serum bilirubin concentration was preoperatively elevated, DRHF was defined by an increasing PT INR and increasing serum bilirubin concentration on or after postoperative day 5 (compared with the values of the previous day).
Measured: postoperative 7 days
Postoperative Liver Regeneration
The postoperative liver regeneration index (LRI) at postoperative 1 month ) was used as surrogate parameters indicating the possible benefits of RIPC. The LRI was defined as [(VLR - VFLR)/VFLR)] × 100, where VLR is the volume of the liver remnant and VFLR is the volume of the future liver remnant. Liver volume was calculated by CT volumetry using 3-mm-thick dynamic CT images. The graft weight was subtracted from the total liver volume to define the future liver remnant.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start22 Aug 2016
- Primary completion31 Aug 2017
- Study completion30 Oct 2017
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.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Tissue DonorsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study group : remote ischemic preconditioning control group : none
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Gol Song, Asan Medical Center
- Investigators
- Jun-Gol Song, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386435
- Sponsor's protocol ID
- RIPC_donor
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2017
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charlton MR. Improving long-term outcomes after liver transplantation. Clin Liver Dis. 2014 Aug;18(3):717-30. doi: 10.1016/j.cld.2014.05.011.
PubMed 25017085Foley DP, Fernandez LA, Leverson G, Chin LT, Krieger N, Cooper JT, Shames BD, Becker YT, Odorico JS, Knechtle SJ, Sollinger HW, Kalayoglu M, D'Alessandro AM. Donation after cardiac death: the University of Wisconsin experience with liver transplantation. Ann Surg. 2005 Nov;242(5):724-31. doi: 10.1097/01.sla.0000186178.07110.92.
PubMed 16244547Karp SJ, Johnson S, Evenson A, Curry MP, Manning D, Malik R, Lake-Bakaar G, Lai M, Hanto D. Minimising cold ischaemic time is essential in cardiac death donor-associated liver transplantation. HPB (Oxford). 2011 Jun;13(6):411-6. doi: 10.1111/j.1477-2574.2011.00307.x. Epub 2011 Apr 4.
PubMed 21609374Halladin NL. Oxidative and inflammatory biomarkers of ischemia and reperfusion injuries. Dan Med J. 2015 Apr;62(4):B5054.
PubMed 25872540Abu-Amara M, Yang SY, Quaglia A, Rowley P, Tapuria N, Seifalian AM, Fuller BJ, Davidson BR. Effect of remote ischemic preconditioning on liver ischemia/reperfusion injury using a new mouse model. Liver Transpl. 2011 Jan;17(1):70-82. doi: 10.1002/lt.22204.
PubMed 21254347Abu-Amara M, Yang SY, Quaglia A, Rowley P, de Mel A, Tapuria N, Seifalian A, Davidson B, Fuller B. Nitric oxide is an essential mediator of the protective effects of remote ischaemic preconditioning in a mouse model of liver ischaemia/reperfusion injury. Clin Sci (Lond). 2011 Sep;121(6):257-66. doi: 10.1042/CS20100598.
PubMed 21463257Gill R, Kuriakose R, Gertz ZM, Salloum FN, Xi L, Kukreja RC. Remote ischemic preconditioning for myocardial protection: update on mechanisms and clinical relevance. Mol Cell Biochem. 2015 Apr;402(1-2):41-9. doi: 10.1007/s11010-014-2312-z. Epub 2015 Jan 1.
PubMed 25552250Bjornsson B, Winbladh A, Bojmar L, Sundqvist T, Gullstrand P, Sandstrom P. Conventional, but not remote ischemic preconditioning, reduces iNOS transcription in liver ischemia/reperfusion. World J Gastroenterol. 2014 Jul 28;20(28):9506-12. doi: 10.3748/wjg.v20.i28.9506.
PubMed 25071345Hwang S, Lee SG, Lee YJ, Sung KB, Park KM, Kim KH, Ahn CS, Moon DB, Hwang GS, Kim KM, Ha TY, Kim DS, Jung JP, Song GW. Lessons learned from 1,000 living donor liver transplantations in a single center: how to make living donations safe. Liver Transpl. 2006 Jun;12(6):920-7. doi: 10.1002/lt.20734.
PubMed 16721780Jung KW, Kim WJ, Jeong HW, Kwon HM, Moon YJ, Jun IG, Song JG, Hwang GS. Impact of Inhalational Anesthetics on Liver Regeneration After Living Donor Hepatectomy: A Propensity Score-Matched Analysis. Anesth Analg. 2018 Mar;126(3):796-804. doi: 10.1213/ANE.0000000000002756.
PubMed 29256938Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Huh IY, Hwang GS. Effect of right ventricular dysfunction on dynamic preload indices to predict a decrease in cardiac output after inferior vena cava clamping during liver transplantation. Transplant Proc. 2010 Sep;42(7):2585-9. doi: 10.1016/j.transproceed.2010.04.041.
PubMed 20832549Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
PubMed 21236455Selzner N, Rudiger H, Graf R, Clavien PA. Protective strategies against ischemic injury of the liver. Gastroenterology. 2003 Sep;125(3):917-36. doi: 10.1016/s0016-5085(03)01048-5.
PubMed 12949736Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P. Regional ischemic 'preconditioning' protects remote virgin myocardium from subsequent sustained coronary occlusion. Circulation. 1993 Mar;87(3):893-9. doi: 10.1161/01.cir.87.3.893.
PubMed 7680290
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on the Postoperative Liver Function in Living Donor Hepatectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03386435
- Acronym / sponsor ID
- RIPC_donor
- Keywords
- remote ischemic preconditioning, liver donors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.
Detailed description
Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).
IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.
Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.
Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- study group : remote ischemic preconditioning control group : none
| Arm | Type | Receives |
|---|---|---|
| RIPC | Experimental | Procedure: remote ischemic preconditioningintervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. |
| Control | No intervention | –In the control group, the same maneuver was applied but without cuff inflation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Donors who plan to have living right hepatectomy for liver transplantation.
- age : between 18 to 60 years.
Key exclusion criteria (3 listed)
- donors who plan to donate left lobe
- donors who plan to have laparoscopic right hepatectomy
- donors who cannot proceed remote ischemic preconditioning
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 |
|---|---|---|
| remote ischemic preconditioningAlso: RIPCRemote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated | Procedure or surgery | RIPC |
Primary outcome
Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days
Time frame: within 7 days after operation
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.
The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days
Time frame: within 7 days after operation
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy
2 secondary outcomes
Number of Participants With Delayed Recovery of Liver Function
Time frame: postoperative 7 days
Postoperative Liver Regeneration
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25017085Charlton MR. Improving long-term outcomes after liver transplantation. Clin Liver Dis. 2014 Aug;18(3):717-30. doi: 10.1016/j.cld.2014.05.011.
- Background: PubMed 16244547Foley DP, Fernandez LA, Leverson G, Chin LT, Krieger N, Cooper JT, Shames BD, Becker YT, Odorico JS, Knechtle SJ, Sollinger HW, Kalayoglu M, D'Alessandro AM. Donation after cardiac death: the University of Wisconsin experience with liver transplantation. Ann Surg. 2005 Nov;242(5):724-31. doi: 10.1097/01.sla.0000186178.07110.92.
- Background: PubMed 21609374Karp SJ, Johnson S, Evenson A, Curry MP, Manning D, Malik R, Lake-Bakaar G, Lai M, Hanto D. Minimising cold ischaemic time is essential in cardiac death donor-associated liver transplantation. HPB (Oxford). 2011 Jun;13(6):411-6. doi: 10.1111/j.1477-2574.2011.00307.x. Epub 2011 Apr 4.
- Background: PubMed 25872540Halladin NL. Oxidative and inflammatory biomarkers of ischemia and reperfusion injuries. Dan Med J. 2015 Apr;62(4):B5054.
- Background: PubMed 21254347Abu-Amara M, Yang SY, Quaglia A, Rowley P, Tapuria N, Seifalian AM, Fuller BJ, Davidson BR. Effect of remote ischemic preconditioning on liver ischemia/reperfusion injury using a new mouse model. Liver Transpl. 2011 Jan;17(1):70-82. doi: 10.1002/lt.22204.
- Background: PubMed 21463257Abu-Amara M, Yang SY, Quaglia A, Rowley P, de Mel A, Tapuria N, Seifalian A, Davidson B, Fuller B. Nitric oxide is an essential mediator of the protective effects of remote ischaemic preconditioning in a mouse model of liver ischaemia/reperfusion injury. Clin Sci (Lond). 2011 Sep;121(6):257-66. doi: 10.1042/CS20100598.
- Background: PubMed 25552250Gill R, Kuriakose R, Gertz ZM, Salloum FN, Xi L, Kukreja RC. Remote ischemic preconditioning for myocardial protection: update on mechanisms and clinical relevance. Mol Cell Biochem. 2015 Apr;402(1-2):41-9. doi: 10.1007/s11010-014-2312-z. Epub 2015 Jan 1.
- Background: PubMed 25071345Bjornsson B, Winbladh A, Bojmar L, Sundqvist T, Gullstrand P, Sandstrom P. Conventional, but not remote ischemic preconditioning, reduces iNOS transcription in liver ischemia/reperfusion. World J Gastroenterol. 2014 Jul 28;20(28):9506-12. doi: 10.3748/wjg.v20.i28.9506.
- Background: PubMed 16721780Hwang S, Lee SG, Lee YJ, Sung KB, Park KM, Kim KH, Ahn CS, Moon DB, Hwang GS, Kim KM, Ha TY, Kim DS, Jung JP, Song GW. Lessons learned from 1,000 living donor liver transplantations in a single center: how to make living donations safe. Liver Transpl. 2006 Jun;12(6):920-7. doi: 10.1002/lt.20734.
- Background: PubMed 29256938Jung KW, Kim WJ, Jeong HW, Kwon HM, Moon YJ, Jun IG, Song JG, Hwang GS. Impact of Inhalational Anesthetics on Liver Regeneration After Living Donor Hepatectomy: A Propensity Score-Matched Analysis. Anesth Analg. 2018 Mar;126(3):796-804. doi: 10.1213/ANE.0000000000002756.
- Background: PubMed 20832549Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Huh IY, Hwang GS. Effect of right ventricular dysfunction on dynamic preload indices to predict a decrease in cardiac output after inferior vena cava clamping during liver transplantation. Transplant Proc. 2010 Sep;42(7):2585-9. doi: 10.1016/j.transproceed.2010.04.041.
- Background: PubMed 21236455Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
- Individual participant dataSharing planned: No
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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-Gol Song, Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning in people with Tissue Donors and Liver Transplantation, run by Asan Medical Center at 1 site in South Korea.
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 2 inclusion and 3 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 19 Aug 2019. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). 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?
Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days (time frame: within 7 days after operation). 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?
On the ClinicalTrials.gov record for NCT03386435, which also lists 24 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 19 Aug 2019.