Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)

March 6, 2020 updated by: Ville Sallinen, Helsinki University Central Hospital

Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial

Remote ischemic preconditioning (RIPC) is a concept where remotely induced ischemia produces protection against ischemia-reperfusion injury in a remote organ. RIPC has been studied extensively in animal models and heart surgery, but it's benefit in transplantation has been studied less. The primary aim of this study is to find out whether RIPC performed in a donor in donation after brain-death (DBD) could improve delayed graft function rate of kidney transplants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Donor Inclusion Criteria:

  • Brain-dead organ donor with a plan of harvesting at least one kidney

Donor Exclusion Criteria:

  • Haemodynamically unstable donor
  • Age below 18 years
  • Planned organ recipients are recruited to another prospective trial, which prevents participation in this trial.

All organ recipients receiving organs (kidney, liver, pancreas-kidney, heart, lungs) from a randomized donor will be recruited providing that the recipient surgery is performed at Helsinki University Hospital, recipient is over 18 years old, and recipient gives written informed consent to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIPC
RIPC will consist of setting a tourniquet to donor thigh and inflating it to 300mmHg four times 5 minutes with 5 minutes deflating in between each. RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.
Procedure: RIPC
Remote Ischaemic Preconditioning
Sham Comparator: Sham-RIPC
Sham-RIPC will consist of setting a tourniquet to donor thigh without inflating it and keeping it in place for 35 min. Sham-RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.
Procedure: Sham-RIPC
Sham procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DGF
Time Frame: 7 days
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kidney allografts: eGFR
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: estimated glomerular filtration rate
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: eGFR
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: estimated glomerular filtration rate
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: BPAR
Time Frame: within 1 year
Kidney allografts: Biopsy proven acute rejection
within 1 year
Combined Pancreas-Kidney allografts: Kidney BPAR
Time Frame: within 1 year
Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft
within 1 year
Kidney allografts: graft survival
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: time from transplantation to death, retransplantation or permanent dialysis
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: kidney graft survival
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: time from transplantation to death, retransplantation of the kidney or permanent dialysis
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: death-censored graft survival
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: time from transplantation to retransplantation or permanent dialysis, death-censored
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: death-censored kidney graft survival
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: time from transplantation to retransplantation of the kidney or permanent dialysis, death-censored
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Liver allografts: MEAF-score at 3rd POD
Time Frame: 3rd post-operative day
Liver allografts: Model for Early Allograft Function Scoring (MEAF) (MEAF = (score ALTmax:3POD+ score INRmax:3POD+ score bilirubin3POD), score range 0 - 10, higher score indicates worse outcome)
3rd post-operative day
Liver allografts: Postoperative biliary complications
Time Frame: within 1 year
Liver allografts: Amount and type of postoperative biliary complications: stricture at anastomosis, bile leak, ischaemic type biliary lesions (ITBL)
within 1 year
Liver allografts: Posttransplantation kidney injury
Time Frame: within 1 week, at 3 months, 1 year
Liver allografts: Posttransplantation kidney injury (acute kidney injury) according to ADQI (2010) criteria
within 1 week, at 3 months, 1 year
Liver allografts: BPAR
Time Frame: within 1 year
Liver allografts: Biopsy proven acute rejection
within 1 year
Liver allografts: graft survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Liver allografts: graft survival: time from transplantation to death, retransplantation or explantation
at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: HbA1c
Time Frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: blood HbA1c measurement
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Acute rejection
Time Frame: within 1 year
Pancreas allografts: Either biopsy proven (allograft pancreas or duodenal biopsy) acute rejection or clinically treated suspected acute rejection
within 1 year
Pancreas allografts: Pancreatic allograft survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Time from transplantation to death, retransplantation, explantation or daily insulin dependance
at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Death-censored Pancreatic allograft survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Time from transplantation to retransplantation, explantation or daily insulin dependance, death-censored
at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: TnI at 6 hours
Time Frame: at 6 hours
Heart allograft: blood TnI measurement at 6 hours after transplantation
at 6 hours
Heart allograft: proBNP at 1 week
Time Frame: at 1 week
Heart allograft: blood proBNP measurement at 1 week after transplantation (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols)
at 1 week
Heart allograft: Primary graft dysfunction
Time Frame: within 24 hours after transplantation
Heart allograft: Primary graft dysfunction according to ISHLT (2014)
within 24 hours after transplantation
Heart allograft: acute rejection
Time Frame: within 1 year
Heart allograft: Biopsy proven or clinically treated acute rejection
within 1 year
Heart allograft: Vasculopathy-free survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: Vasculopathy-free survival according to Mehra (2010)
at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: graft survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: time from transplantation to death, retransplantation or explantation
at 1 year, 2 year, 5 year, 10 year, and 20 year
Lung allograft: Primary graft dysfunction
Time Frame: within 72 hours
Lung allograft: Primary graft dysfunction according to ISHLT
within 72 hours
Lung allograft: Acute rejection
Time Frame: within 1 year
Lung allograft: Biopsy proven or clinically treated acute rejection
within 1 year
Lung allograft: CLAD-free survival
Time Frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Lung allograft: Chronic Lung Allograft Dysfunction (CLAD) free survival according to Verleden (2014)
at 1 year, 2 year, 5 year, 10 year, and 20 year
Lung allograft: graft survival
Time Frame: at 1, 2, 5, 10 and 20 year
Lung allograft: time from transplantation to death, retransplantation or explantation (12/16/2019 secondary outcome measures for lung recipients redifined. Lung recipients recruitment started later than for other organs because of a conflicting trial which now has completed recruiting. Only four lung patients have thus far been included in the study and no results for lung recipients have been analyzed.)
at 1, 2, 5, 10 and 20 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory outcomes Kidney allograft miR-21
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples micro-RNA miR-21
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft miR-24
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples micro-RNA miR-24
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft NGAL
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples neutrophil gelatinase associated lipocain NGAL
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft KIM-1
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples kidney injury molecule -1 KIM-1
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft FABP-1
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples fatty acid binding protein -1 FABP-1
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft SLPI
Time Frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Measurement of reperfusion injury in blood and urine samples secretory leucocyte proteinase inhibitor SLPI
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Liver allograft: Early allograft dysfunction
Time Frame: at 7 days
Exploratory outcomes Liver allograft: Early allograft dysfunction according to Olthoff (Bil >100, INR 1.6 or more, ALT or AST > 2000 at 7th POD
at 7 days
Exploratory outcomes Liver allograft: Highest ALT within 7th POD
Time Frame: within 7 days
Exploratory outcomes Liver allograft: The highest ALT measurement within 7th POD
within 7 days
Exploratory outcomes Liver allograft: Highest INR within 7th POD
Time Frame: within 7 days
Exploratory outcomes Liver allograft: The highest INR measurement within 7th POD
within 7 days
Exploratory outcomes Liver allograft: Highest Bil within 7th POD
Time Frame: within 7 days
Exploratory outcomes Liver allograft: The highest Bil measurement within 7th POD
within 7 days
Exploratory outcomes heart allografts: TnI
Time Frame: at 1 hour, 12 hours and 24 hours
Exploratory outcomes heart allografts: TnI measurement
at 1 hour, 12 hours and 24 hours
Exploratory outcomes heart allografts: proBNP
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols)
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: crea
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: crea
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: urea
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: urea
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: eGFR
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: eGFR
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: LVEF
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: left ventricle ejection fraction
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: LV wall thickness
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: left ventricle wall thickness measurements
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: tricuspidal leak
Time Frame: at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: grading of the tricuspidal valve leak
at 1 day, 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: Ischaemia-reperfusion injury
Time Frame: at 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: The appearance of ischaemia-reperfusion injury in routine biopsies
at 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: fibrosis
Time Frame: at 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: The appearance of fibrosis associated factors in routine biopsies
at 7 days, 14 days and 21 days
Exploratory outcomes heart allografts: long time follow-up of proBNP
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes heart allografts: long time follow-up of proBNP (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols)
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes heart allografts: long time follow-up of LVEF
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes heart allografts: long time follow-up of left ventricle ejection fraction in cardiac ECHO
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes heart allografts: CAD at 1 year
Time Frame: at 1 year
Exploratory outcomes heart allografts: Coronary Artery Disease in coronary angiography at 1 year
at 1 year
Exploratory outcomes heart allografts: MACE
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes heart allografts: Major Adverse Cardiac Events (including death because of cardiac cause, graft loss, primary allograft dysfunction, rejection classified as 2R or more)
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury standardized P/F-ratio
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation: standardized P/F-ratio during mechanical ventilation
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: non-standardized P/F-ratio
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation: non-standardized P/F-ratio during mechanical ventilation
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: lactate
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation , plasma lactate,
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: CRP
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation: serum highly sensitive C-reactive protein
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: leuc
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation blood leukocyte count
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: neut
Time Frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Severity of ischemia/reperfusion injury after transplantation neutrophil count
at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Exploratory outcomes lung allografts: FEV1
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: FEV1
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: FVC
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: FVC
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: chronic rejection
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: chronic rejection
at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: infections
Time Frame: at 1 month, 3 months, 6 months, 12 months
Exploratory outcomes lung allografts: infections after transplantation
at 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academy of Finland
Finska Läkaresällskapet (funding)
Helsinki University Hospital Research Funds (funding)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aki Uutela, MD, Helsinki University Central Hospital
  • Study Chair: Marko Lempinen, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2042

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIPTRANS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the completion of the study the depersonalized data can be requested from the authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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