HemorrhagePhase 3NCT03343704

This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

A Phase 3 study testing Idarucizumab in people with Hemorrhage, run by Boehringer Ingelheim at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemorrhage
What is being tested?: Idarucizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 13 sitesChina
Study dates: 26 Mar 2018to 2 Jul 2020
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years at screening.
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Currently taking dabigatran etexilate
They meet the following criteria:
Group A: Overt bleeding judged by the physician to require a reversal agent. OR
Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Who cannot join

Group A:
Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
Patients with no clinical signs of bleeding.
Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Group B:
A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

China13 sites

Beijing AnZhen Hospital
Beijing, 100029
Peking University First Hospital
Beijing, 100034
Cardiovascular Institute and Fu Wai Hospital
Beijing, 100037
First Affiliated Hospital of Dalian Medical University
Dalian, 116011
Guangdong Provincial People's Hospital
Guangzhou, 510080
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Guangzhou, 510288
2nd Affiliated Hosp Zhejiang University College of Medical
Hangzhou, 310009
Zhejiang Province People's Hospital
Hangzhou, 310014
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
Jiangsu Province Hospital
Nanjing, Jiangsu Province, 210029
Shanghai First People's Hospital
Shanghai, 200080
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 830054
The First Affiliated Hospital of Wenzhou Med College
Wenzhou, 325000

Other trials in China

About this study

Official title: A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Conditions: Hemorrhage
Being tested: Idarucizumab
Medical subject headings: Hemorrhage

What participants receive

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

IdarucizumabDrug
Also called PRAXBIND, Praxbind, Prizbind
Intravenous

Study groups in NCT03343704
Study group	Role	What they receive
Group A - patients with uncontrolled or life-threatening bleeding	Experimental	Not described Receives: Drug: Idarucizumab
Group B - patients not bleeding but requiring emergency surgery or invasive procedure	Experimental	Not described Receives: Drug: Idarucizumab

What is being measured

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

Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported.
The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds.
Measured: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported.
The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds.
Measured: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Secondary outcomes (15)

Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
Measured: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery
Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported.
Measured: Up to 24 hours post-surgery.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported.
Measured: Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.
The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 39.80 seconds.
Measured: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)
Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported.
The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is > 100, it was set to 100. 100% ULN is 14.22 seconds.
Measured: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Numbers of Participants With Any Adverse Events - on Treatment
Numbers of participants with any adverse events during on treatment period is reported.
Measured: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Numbers of participants with any adverse events until end of study is reported.
Measured: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Serious Adverse Events - on Treatment
Number of participants with Serious adverse events during on treatment period is reported.
Measured: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Serious Adverse Events - Including Post Treatment Period
Number of participants with Serious adverse events until the end of study is reported.
Measured: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Drug-related Adverse Events - on Treatment
Numbers of patients with drug-related adverse events during on treatment period is reported.
Measured: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Numbers of patients with drug-related adverse events until end of study is reported.
Measured: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Immune Reaction Adverse Event - on Treatment
Number of participants with immune reaction adverse event during on treatment period is reported.
Measured: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Number of participants with immune reaction adverse event until end of study is reported.
Measured: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Thrombotic Events - on Treatment
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
Measured: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Thrombotic Events - Including Post Treatment Period
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
Measured: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.

Timeline

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

26 Mar 20182 Jul 2020

First posted17 Nov 2017
Study start26 Mar 2018
Primary completion2 Jul 2020
Study completion2 Jul 2020

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 HemorrhageStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03343704
Sponsor's protocol ID: 1321-0019
Status last verified: Feb 2025
First submitted: 13 Nov 2017
Last updated: 25 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion

All Hemorrhage trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
ClinicalTrials.gov ID: NCT03343704
Acronym / sponsor ID: 1321-0019
Conditions: Hemorrhage
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 26 Mar 2018 (actual)
Primary completion: 2 Jul 2020 (actual)
Study completion: 2 Jul 2020 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 20 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A - patients with uncontrolled or life-threatening bleeding	Experimental	Drug: Idarucizumab
Group B - patients not bleeding but requiring emergency surgery or invasive procedure	Experimental	Drug: Idarucizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

≥ 18 years at screening.
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Currently taking dabigatran etexilate
They meet the following criteria:

Key exclusion criteria (7 listed)

Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
Patients with no clinical signs of bleeding.
Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

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
IdarucizumabAlso: PRAXBIND, Praxbind, PrizbindIntravenous	Drug	Group A - patients with uncontrolled or life-threatening bleeding, Group B - patients not bleeding but requiring emergency surgery or invasive procedure

Primary outcome

Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds.

15 secondary outcomes

Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Time frame: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery
Time frame: Up to 24 hours post-surgery.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
Time frame: Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Numbers of Participants With Any Adverse Events - on Treatment
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Serious Adverse Events - on Treatment
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Serious Adverse Events - Including Post Treatment Period
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Drug-related Adverse Events - on Treatment
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Immune Reaction Adverse Event - on Treatment
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Thrombotic Events - on Treatment
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Thrombotic Events - Including Post Treatment Period
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.

Results and safety

Results posted to the registry on 20 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A - Patients With Uncontrolled or Life-threatening Bleeding	13	12
Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure	6	4

Primary outcome: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time

Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.. Median (95% Confidence Interval). Unit: Percentage

Measure	Group A - Patients With Uncontrolled or Life-threatening Bleeding n = 6	Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure n = 4	Total n = 10
Value	100.0 (100.0 to 100.0)	100.0 (96.8 to 100.0)	100.0 (100.0 to 100.0)

Population analysed: Pharmacodynamic (PD) set (PDS): comprise all patients in the treated set who provided at least one evaluable pre-dose and at least one post-dose observation for PD endpoints or biomarker measures. Only participants with non-missing outcomes are included in the analysis.

Primary outcome: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time

Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.. Median (95% Confidence Interval). Unit: Percentage

Measure	Group A - Patients With Uncontrolled or Life-threatening Bleeding n = 5	Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure n = 4	Total n = 9
Value	100.0 (100.0 to 100.0)	100.0 (100.0 to 100.0)	100.0 (100.0 to 100.0)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A - Patients With Uncontrolled or Life-threatening Bleeding	7 of 13 (53.8%)	13 of 13 (100%)	0 of 13
Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure	3 of 6 (50%)	6 of 6 (100%)	1 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Hemorrhage

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idarucizumab in people with Hemorrhage, run by Boehringer Ingelheim at 13 sites in China.

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 7 inclusion and 7 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Aug 2021). 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?

Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time (time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.). 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 NCT03343704.

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 25 Feb 2025.