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NCT04203680
Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in CABG
EARLY_PHASE1 trial testing HTK cardioplegic solution in Cardioplegia Solution Adverse Reaction in 320 participants. Completed in 25 April 2020.
31 March 2020
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 320 |
| Start date | 25 December 2019 |
| Primary completion | 31 March 2020 |
| Estimated completion | 25 April 2020 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
- HTK cardioplegic solution — full drug profile →
- blood cardioplegia — full drug profile →
Conditions studied
- Cardioplegia Solution Adverse Reaction — all drugs for Cardioplegia Solution Adverse Reaction →
Sponsor
Ain Shams University
Who can join
Adults 60 to 80, any sex, with Cardioplegia Solution Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: In cardiac surgery, myocardial protection is mandatory during cross clamp time followed by reperfusion. Use of cardioplegic solutions preserves myocardial energy stores, hindering electrolyte disturbances and acidosis during periods of myocardial ischemia. This study was designed to compare the efficacy and safety of Histidine-tryptophan-ketoglutarate (HTK) solution versus blood cardioplegia in coronary artery bypass graft surgery. Methods: Three hundred and twenty patients were randomized into Histidine-tryptophan-ketoglutarate (HTK) group and blood cardioplegia group. Ventilation time, total bypass time, cross clamp time, length of ICU or hospital stay and the early postoperative outcomes were analysed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Warm versus cold cardioplegia in cardiac surgery: A meta-analysis with trial sequential analysis.
Kot TKM, Chan JSK, Froghi S, Lau DHH, et al · · 2021 · cited 1× · PMID 36003589 · DOI 10.1016/j.xjon.2021.03.011
Verify or expand the search:
- PubMed search for NCT04203680
- Europe PMC full search
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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 NCT04203680 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 7 May 2020
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/NCT04203680.
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