Intraventricular HemorrhagePhase 1NCT06814964
rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage
A Phase 1 study testing Low dose group, Medium dose group and High dose group in people with Intraventricular Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- Low dose group, Medium dose group and High dose group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring during sleep, the time of symptom onset should be considered as the last time the patient was awake and asymptomatic.
- Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) >20 ml obstructing the third and/or fourth ventricles.
- All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest cerebrospinal fluid (CSF) pool or the least bloody site in the lateral ventricle using robotic stereotactic guidance.
- A stability CT scan performed ≥ 6 hours after EVD placement must confirm ICH clot stability: The ICH volume change should be ≤ 5 ml compared to the previous CT scan. If the stability CT scan shows a difference > 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a hematoma enlargement ≤ 5 ml and the ICH volume remains ≤ 35 ml, the patient is eligible.
- IVH clot stability: The width of the lateral ventricle most affected by the clot must not increase by > 2 mm. If the stability CT scan shows a difference > 2 mm, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a change ≤ 2 mm, the patient is eligible.
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- Catheter tract bleeding on the stability CT scan must be ≤ 5 ml. If any CT slice shows catheter tract bleeding > 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a change ≤ 5 ml and the total hematoma volume along the tract is ≤ 10 ml, the patient is eligible.
- On the stability CT scan, the third and/or fourth ventricles must be occluded with blood.
- Primary IVH (ICH = 0) is eligible.
- Sustained systolic blood pressure (SBP) < 180 mmHg for at least 6 hours prior to enrollment. (Patients do not need to meet the SBP criteria throughout the screening period, but vital signs should remain stable during the enrollment window).
- No intraventricular thrombolytic treatment within 12 hours of symptom onset.
- Enrollment must be completed within 72 hours of the diagnostic CT scan. (The 72-hour limit may be extended with PI approval for reasons such as hematoma stability, INR stability, or other valid justifications).
- Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
Who cannot join
- Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or other definitive imaging must be performed during screening to rule out these causes. If imaging is negative, the patient is eligible.
- Presence of choroid plexus vascular malformation or Moyamoya disease.
- Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if long-term anticoagulation is not required.
- Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within one week prior to symptom onset (aspirin is allowed).
- Platelet count < 100,000 or INR > 1.4.
- Pregnancy (positive serum or urine pregnancy test).
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- Infratentorial hemorrhage.
- Thalamic hemorrhage with significant midbrain extension, third nerve palsy, or dilated and non-reactive pupils. Other supranuclear gaze abnormalities are not excluded. Posterior fossa or cerebellar hemorrhages are excluded.
- Subarachnoid hemorrhage (SAH) or any atypical hematoma location or appearance on diagnostic CT scan. Angiography (CTA, DSA, or MRA/MRI) must be performed to rule out other causes. If no source of bleeding is identified, the patient is eligible. Cortical SAH secondary to clot lysis is eligible.
- Unstable ICH/IVH with ongoing hematoma enlargement.
- Indications for craniotomy: ① Progressive decline in consciousness; ② Signs of brain herniation; ③ Hematoma located < 1 cm from the cortical surface.
- Ongoing internal bleeding involving retroperitoneal, gastrointestinal, genitourinary, or respiratory tracts. Patients with prior bleeding that is clinically stable for ≥ 12 hours and without coagulopathy or bleeding disorders are eligible.
- Multifocal superficial bleeding at multiple vascular puncture or access sites (e.g., venipuncture, arterial puncture) or recent surgical sites.
- Any condition that, in the investigator's opinion, poses a significant risk to the patient or makes the patient unsuitable for the study.
- Planned or concurrent participation in another interventional clinical trial. Participation in observational, natural history, or epidemiological studies without intervention is allowed.
- Inability to obtain informed consent from the patient or legal representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yong Cao, +86 13601362306, caoyong@bjtth.org
Shaozhi Zhao, +86 18801217693, sdsgzsz@163.com
About this study
Official title: A Phase I Pilot Clinical Trial of Dose Escalation With Stereotactic-Guided Intraventricular Thrombolysis Using Tenecteplase (rhTNK-tPA) for Intraventricular Hemorrhage.
The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.
Read the detailed description
In patients with spontaneous intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH) is often associated with catastrophic outcomes. Studies have reported that the mortality rate in ICH patients with IVH exceeds 50%, and fewer than 20% of survivors achieve good functional outcomes. Hematoma lysis therapy appears to influence both mortality and functional recovery. Previous systematic reviews and meta-analyses suggest that the removal of intraventricular hemorrhage, by alleviating acute obstructive hydrocephalus and reducing neurotoxicity, may improve survival rates and long-term functional outcomes. The CLEAR III trial, published in The Lancet, demonstrated that in patients with IVH and external ventricular drainage, the 180-day mortality rate was lower with intraventricular alteplase lavage compared to saline (0.9%), although functional outcomes did not improve.
Alteplase, a second-generation fibrinolytic agent, facilitates the dissolution of hematomas following intraventricular hemorrhage. However, its low fibrin specificity, short half-life, and weak resistance to plasminogen activator inhibitor type 1 (PAI-1) often necessitate multiple thrombolytic administrations. This may explain the lack of improvement in neurological functional outcomes. In contrast, tenecteplase, a third-generation fibrinolytic agent, exhibits higher fibrin specificity and a longer half-life, which may enhance thrombolytic efficiency and hematoma clearance rates. These properties make tenecteplase a potentially safer and more effective option for hematoma dissolution in patients with intraventricular hemorrhage.
Building on the findings of the CLEAR III trial and previous research, this study aims to replace alteplase with tenecteplase and conduct a prospective, single-center, "3+3" dose-escalation trial to evaluate the safety and optimal dosing of tenecteplase-assisted hematoma dissolution for intraventricular hemorrhage. The results will provide a foundation for future multicenter randomized controlled trials.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Low dose group, Medium dose group, High dose group
- Keywords
- intraventricular hemorrhage, Stereotactic puncture therapy, rhTNK-tPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose groupDrug
The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.
Medium dose groupDrug
The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.
High dose groupDrug
The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.
| Study group | Role | What they receive |
|---|---|---|
| Low dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | Low dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. Receives: Drug: Low dose group |
| Medium dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | Medium dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. Receives: Drug: Medium dose group |
| High dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | High dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. Receives: Drug: High dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-related new rebleeding events
CT examinations were performed every 24 hours after tenecteplase administration. Compared with the CT at the previous time point, a CT value of more than 72 HU and a volume of more than 5 ml were defined as newly emitted blood.
Measured: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
Secondary outcomes (5)
Mortality rate
Death within 7 days of enrollment
Measured: within 7 days of enrollment
Ventricular infection
fever and positive cerebrospinal fluid culture
Measured: within 7 days of enrollment
Clot Removal
Change in blood volume measured between stability scan and 24 hours after the last dose.
Measured: 24 hours after the last dose.
Number of doses administered at the endpoint of the treatment
Record the number of doses administered at the endpoint of the treatment.
Measured: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
The rate of resolution of 3rd and/or 4th ventricles obstruction at the endpoint of treatment.
CT examinations were performed every 24 hours after tenecteplase administration to determine the resolution of 3rd and/or 4th ventricles obstruction.
Measured: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
- Investigators
- Yong Cao, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814964
- Sponsor's protocol ID
- rhTNK-tPA-IVH01
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Clinical Trial of Dose Escalation With Stereotactic-Guided Intraventricular Thrombolysis Using Tenecteplase (rhTNK-tPA) for Intraventricular Hemorrhage.
- ClinicalTrials.gov ID
- NCT06814964
- Acronym / sponsor ID
- rhTNK-tPA-IVH01
- Conditions
- Intraventricular Hemorrhage
- Keywords
- intraventricular hemorrhage, Stereotactic puncture therapy, rhTNK-tPA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.
Detailed description
In patients with spontaneous intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH) is often associated with catastrophic outcomes. Studies have reported that the mortality rate in ICH patients with IVH exceeds 50%, and fewer than 20% of survivors achieve good functional outcomes. Hematoma lysis therapy appears to influence both mortality and functional recovery. Previous systematic reviews and meta-analyses suggest that the removal of intraventricular hemorrhage, by alleviating acute obstructive hydrocephalus and reducing neurotoxicity, may improve survival rates and long-term functional outcomes. The CLEAR III trial, published in The Lancet, demonstrated that in patients with IVH and external ventricular drainage, the 180-day mortality rate was lower with intraventricular alteplase lavage compared to saline (0.9%), although functional outcomes did not improve.
Alteplase, a second-generation fibrinolytic agent, facilitates the dissolution of hematomas following intraventricular hemorrhage. However, its low fibrin specificity, short half-life, and weak resistance to plasminogen activator inhibitor type 1 (PAI-1) often necessitate multiple thrombolytic administrations. This may explain the lack of improvement in neurological functional outcomes. In contrast, tenecteplase, a third-generation fibrinolytic agent, exhibits higher fibrin specificity and a longer half-life, which may enhance thrombolytic efficiency and hematoma clearance rates. These properties make tenecteplase a potentially safer and more effective option for hematoma dissolution in patients with intraventricular hemorrhage.
Building on the findings of the CLEAR III trial and previous research, this study aims to replace alteplase with tenecteplase and conduct a prospective, single-center, "3+3" dose-escalation trial to evaluate the safety and optimal dosing of tenecteplase-assisted hematoma dissolution for intraventricular hemorrhage. The results will provide a foundation for future multicenter randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | Drug: Low dose groupLow dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. |
| Medium dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | Drug: Medium dose groupMedium dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. |
| High dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage | Experimental | Drug: High dose groupHigh dose tenecteplase (injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. At least 4 ml of CSF is removed prior to injection of 1 ml of test article followed by a 3 ml flush of sterile saline into the ventricle. Injection is followed by closure of the catheter for 1 hour and then opening of the EVD for drainage of clot and CSF until the next injection every 12 hours. Treatment continues for up to 8 doses of test article unless, an treatment success endpoint of clot lysis is reached, or an adverse treatment endpoint occurs (e.g. new hemorrhage: compared with the previous time point CT, a CT value of > 72Hu and a volume of > 5ml). Treatment success endpoints are (i) both 3rd and 4th ventricles are open; (ii) IVH related mass effect [dilated or shifted ventricle] is resolved; or (iii) an estimated 80% resolution of the IVH clot has occurred from the time clot stability was established. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-80 years.
- Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring during sleep, the time of symptom onset should be considered as the last time the patient was awake and asymptomatic.
- Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) >20 ml obstructing the third and/or fourth ventricles.
- All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest cerebrospinal fluid (CSF) pool or the least bloody site in the lateral ventricle using robotic stereotactic guidance.
- A stability CT scan performed ≥ 6 hours after EVD placement must confirm ICH clot stability: The ICH volume change should be ≤ 5 ml compared to the previous CT scan. If the stability CT scan shows a difference > 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a hematoma enlargement ≤ 5 ml and the ICH volume remains ≤ 35 ml, the patient is eligible.
Key exclusion criteria (16 listed)
- Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or other definitive imaging must be performed during screening to rule out these causes. If imaging is negative, the patient is eligible.
- Presence of choroid plexus vascular malformation or Moyamoya disease.
- Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if long-term anticoagulation is not required.
- Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within one week prior to symptom onset (aspirin is allowed).
- Platelet count < 100,000 or INR > 1.4.
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 |
|---|---|---|
| Low dose groupThe calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. | Drug | Low dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage |
| Medium dose groupThe calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. | Drug | Medium dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage |
| High dose groupThe calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD. | Drug | High dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhage |
Primary outcome
Drug-related new rebleeding events
Time frame: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
CT examinations were performed every 24 hours after tenecteplase administration. Compared with the CT at the previous time point, a CT value of more than 72 HU and a volume of more than 5 ml were defined as newly emitted blood.
5 secondary outcomes
Mortality rate
Time frame: within 7 days of enrollment
Ventricular infection
Time frame: within 7 days of enrollment
Clot Removal
Time frame: 24 hours after the last dose.
Number of doses administered at the endpoint of the treatment
Time frame: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
The rate of resolution of 3rd and/or 4th ventricles obstruction at the endpoint of treatment.
Time frame: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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.
Yong Cao principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose group, Medium dose group and High dose group in people with Intraventricular Hemorrhage, run by Beijing Tiantan Hospital at 1 site 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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao (+86 13601362306, caoyong@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-related new rebleeding events (time frame: 24, 48, 72, and 96 hours after the first dose tenecteplase administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.