What clinical trials have reported side effects of gelatide and their frequencies?
Executive summary
Clinical trials and systematic reviews report safety concerns for gelatin-containing products used as plasma expanders: meta-analyses pooled dozens of trials (30 RCTs with 3,629 patients in one review; 72 RCTs with 5,915 patients in another synthesis) and found signals for allergic reactions (including anaphylaxis), possible renal injury and coagulation issues [1] [2]. Individual randomized trials are usually small, often report few events, and many had zero events for serious reactions making precise frequencies hard to establish from available trial reports [3] [2].
1. What the clinical-trial literature actually studied: gelatin as a volume expander
Most clinical trials in the supplied records tested gelatin solutions as plasma/volume expanders in hypovolemia or as priming fluids for cardiopulmonary bypass, not “gelatide” as a branded drug entity; systematic reviews aggregated randomized and nonrandomized trials spanning the 1970s–2010s to evaluate mortality, renal function, bleeding and allergic reactions after gelatin versus crystalloids or albumin [2] [1].
2. Size and scope of the evidence base: many small trials, pooled for power
A comprehensive review identified 30 RCTs with 3,629 patients (search up to 2015) and a separate systematic review described 72 RCTs with 5,915 patients published between 1975 and 2010; reviewers pooled these small trials because individual studies were often underpowered to detect rare but severe harms [1] [2].
3. Reported adverse events and how often they show up in trials
Meta-analyses and reviews report a higher rate of allergic reactions — including anaphylaxis — associated with gelatin fluids in pooled analyses, and they flagged possible increased acute kidney injury (AKI) and bleeding in some comparisons; however, many trials recorded zero events for anaphylaxis or other serious harms, making frequency estimates imprecise [1] [3] [4].
4. Why published frequencies are unreliable or inconsistent
Review authors repeatedly note that most trials were small, short-duration, and used control fluids that may themselves carry risks. The presence of many “zero-event” trials (trials reporting no anaphylaxis in either arm) produced “not estimable” risk ratios in some meta-analyses, which limits confidence in numerical frequency estimates from pooled data [3] [2].
5. Divergent interpretations among expert reports
Some systematic reviewers conclude gelatin “may have serious adverse effects” and caution against its use given safer, cheaper alternatives [1]. Other older clinical reports and single-center experience argued for acceptable safety — e.g., a retrospective clinical-experience review that reported no dosage-related side effects over long use — highlighting disagreement based on dataset and era [5] [1].
6. Specific serious harms flagged in the literature
The literature highlights allergic reactions and anaphylaxis, possible increases in AKI in septic and cardiac surgery patients, and concerns about coagulation/bleeding; these signals appear across meta-analyses and systematic reviews rather than as consistent high-frequency events in single trials [6] [4] [1].
7. Examples of trial contexts where harms were assessed
Trials cover perioperative use, resuscitation of hypovolemia, and priming during cardiopulmonary bypass. Reviews emphasize that in critically ill or septic patients and some cardiac-surgery cohorts, retrospective analyses and pooled data suggested higher AKI rates in gelatin recipients versus crystalloids, but the evidence quality was judged low to moderate [4] [2].
8. What’s missing from the available sources about “gelatide” specifically
Available sources discuss gelatin or gelatin-based plasma expanders, succinylated gelatin, and gelatin capsules; they do not mention a drug named “gelatide.” Therefore, specific clinical-trial safety data for an entity called “gelatide” are not found in current reporting (available sources do not mention gelatide).
9. Practical takeaway for clinicians and patients
Systematic reviews pooling many small trials show safety signals (allergy/anaphylaxis, possible AKI and bleeding) that warrant caution when choosing gelatin for volume resuscitation; reviewers advise preferring alternatives with better safety evidence when feasible, while noting that absolute event frequencies are uncertain because of trial size and reporting limitations [1] [2].
Limitations: this summary relies only on the supplied records; it cannot quantify precise side‑effect frequencies for every trial because many trials reported no events or used heterogeneous designs and comparators [3] [2].