Application of tPA in Suprachoroidal and Subretinal Hemorrhage

NCT05736757 | Recruiting

• 1 other identifier: 2022-0178
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. In the process of waiting for the spontaneous liquefaction of hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage. Local application of tissue fibrinogen activator under the retina can promote the liquefaction of subretinal hemorrhage.

Conditions

Ocular Trauma

Keywords

suprachoroidal hemorrhage; subretinal hemorrhage

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

  Best corrected visual acuity

  through study completion, an average of 2 year

Secondary Outcomes (1)

• Intraocular pressure

  through study completion, an average of 2 year

Study Arms (2)

Control group

NO INTERVENTION

Control group (no tissue fibrinogen activator)

Drug group

EXPERIMENTAL

Drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space )

Drug: Tissue Plasminogen Activator

Interventions

Tissue Plasminogen Activator DRUG

Injection of 50 ug tissue plasminogen activator into the suprachoroidal cavity or subretinal space to assist in bleeding liquefaction

Drug group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe ocular rupture accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage

You may not qualify if:

• Rupture of eyeball accompanied by a small amount of suprachoroidal hemorrhage or a small amount of subretinal hemorrhage

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Links

• Tissue plasminogen activator-assisted vitrectomy for ruptured eye with suprachoroidal hemorrhage
• Tissue plasminogen activator-assisted vitrectomy in the early treatment of acute massive suprachoroidal hemorrhage complicating cataract surgery
• Recombinant tissue plasminogen activator in the treatment of suprachoroidal hemorrhage
• Tissue plasminogen activator in the treatment of vitreoretinal diseases
• Treatment of suprachoroidal hemorrhage with tissue plasminogen activator
• Treatment of experimental suprachoroidal hemorrhage with intravenous tissue plasminogen activator

MeSH Terms

Interventions

Tissue Plasminogen Activator

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Central Study Contacts

Zhitao Su, Ph.D

CONTACT

86 0571 87783759; suzhitao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomly divided into control group (without tissue fibrinogen activator) or drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space ).

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: December 1, 2022
• Primary Completion: April 1, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 21, 2023

Record last verified: 2022-07

Locations

CN (1)