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NCT05647161
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
NA trial testing BAX602 in Congenital Heart Disease in Children in 34 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2025
Quick facts
| Lead sponsor | Baxter Healthcare Corporation |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 8 December 2022 |
| Primary completion | 31 October 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 6 locations across Japan |
Drugs / interventions tested
- BAX602
- No Intervention
Conditions studied
- Congenital Heart Disease in Children — all drugs for Congenital Heart Disease in Children →
Sponsor
Baxter Healthcare Corporation — full company profile →
Who can join
Adults 0 to 12, any sex, with Congenital Heart Disease in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe conditions. In the course of a staged surgical intervention, adhesion formation around the heart and large vessels can occur, and dissection of the adhesion site is required at the time of reoperation. There is a concern that dissection may markedly increase the risk of operation such as prolonged surgical time, cardiovascular injury, and increased blood loss, and medical devices to prevent adhesion formation after operation in the field of pediatric cardiovascular operation are strongly desired in medical settings. The investigational product (BAX602), which has already been manufactured and marketed by Baxter overseas, has been used for open heart surgery as a local hemostatic agent without biological materials in Europe and the US for more than 20 years. However, since it has not been approved in Japan, this randomized controlled study will be conducted in Japan to demonstrate the effect of BAX602 to prevent and reduce adhesion formation between the surface of the heart/large vessels and surrounding tissues in pediatric patients undergoing planned multistage operation for congenital heart disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05647161
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Baxter Healthcare Corporation trials
Trials by the same sponsor.
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- NCT07158333 — Mobile Cardiac Telemetry (MCT) Study · completed
- NCT06842121 — A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Ph · Phase 1 · completed
- NCT06842134 — A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E · Phase 1 · completed
- NCT05996809 — PMCF Study for COSEAL® in Gynecologic Surgery · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05647161 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baxter Healthcare Corporation
- Last refreshed: 22 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05647161.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing